ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K082142 |
|---|---|
| Device Name | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Siemens Medical Solutions USA, Inc., Ultrasound DI |
| Product Code | IYN · Radiology |
| Decision Date | Nov 13, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Device Story
Acuson S2000 is a diagnostic ultrasound system for imaging and fluid flow analysis. It processes acoustic signals from various transducers (curved, linear, phased array) to produce real-time 2D, 3D, and Doppler images. Operated by clinicians in clinical settings, it provides anatomical measurements and calculation packages to assist in diagnosis. Features include tissue harmonic imaging, spatial compounding, panoramic imaging, contrast agent imaging, and elasticity imaging. Output is displayed for physician review to support clinical decision-making across multiple specialties including cardiac, OB/GYN, and vascular applications.
Clinical Evidence
Bench testing only. The device complies with safety standards including UL 60601-1, IEC 60601-2-37, and ISO 10993-1 for biocompatibility. No clinical data was required for this 510(k) submission.
Technological Characteristics
Diagnostic ultrasound system using pulsed echo and Doppler imaging. Transducers include curved, linear, and phased arrays. Connectivity includes standard ultrasound interfaces. Safety standards: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3. Biocompatibility per ISO 10993-1. Features: Ensemble tissue harmonic imaging, SieClear spatial compounding, 3-Scape 3D imaging, Cadence contrast imaging, SieScape panoramic imaging, Clarity VE vascular enhancement, and eSie Touch elasticity imaging.
Indications for Use
Indicated for fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, and musculoskeletal imaging and measurement in patients requiring diagnostic ultrasound or fluid flow analysis.
Regulatory Classification
Identification
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
- Acuson Antares Ultrasound System
Submission Summary (Full Text)
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Product Code 90-ITX
Kof2/42
### 510(k) Summary Prepared October 27, 2008
| Sponsor: | Siemens Medical Solutions, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>Mountain View, California 94043 | NOV 13 2008 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Shelly Pearce<br>Telephone: (650) 694-5988<br>Fax: (650) 694-5580 | |
| Submission Date: | October 13, 2008 | |
| Device Name: | Acuson S2000TMUltrasound System | |
| Common Name: | Diagnostic Ultrasound System | |
| Classification: | | |
| Regulatory Class: | II | |
| Review Category: | Tier II | |
| Classification Panel: | Radiology | |
| | Ultrasonic Pulsed Doppler Imaging System FR # 892.1550<br>Product Code 90-IYN<br>Ultrasonic Pulsed Echo Imaging System FR # 892.1560<br>Product Code 90-IYO | |
FR # 892.1570
### A. Legally Marketed Predicate Devices
Diagnostic Ultrasound Transducer
The Acuson S2000™Ultrasound System is substantially equivalent to the Acuson Antares Ultrasound System.
### B. Device Description:
The Acuson S2000™ has been designed to meet the following product safety standards:
- " UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical l Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 트 93/42/EEC Medical Devices Directive
- r Safety and EMC Requirements for Medical Equipment
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- EN/IEC 60601-1 .
- . EN/IEC 60601-1-1
- . EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power *
- ISO 10993-1 Biocompatibility ■
S2000 510(k) Submission
{1}------------------------------------------------
### C. Intended Use
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
S2000 510(k) Submission
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the symbol.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# NOV 1 3 2008
Ms. Shelly Pearce Regulatory Affairs Siemens Medical Solutions USA, Inc. P.O. Box 7393, 1230 Shorebird Way MOUNTAIN VIEW CA 94039
Re: K082142
Trade/Device Name: Acuson S2000™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 17, 2008 Received: September 22, 2008
Dear Ms. Pearce:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against. misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the Acuson S2000™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
CW2 Probe CW5 Probe EC9-4 Curved Array 9L4 Linear Array 14L5 Multi-D Arrav 4P1 Phased Array 6C2 Curved Array 4C1 Curved Array 4V1 Phased Array
{3}------------------------------------------------
10V4 Phased Array 14L5 SP Linear Array 7CF2 Curved Array 9EVF4 Curved Array V5Ms Multiplane TEE 17L5HDS Linear Array 18L6 HD Linear Array 8V3 Phased Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Herbert Weiner
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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1.3 Indications for Use
510(k) Number (if known): K082142
Device Names \$3000M Diganestis
Device Name: S2000™Diagnostic Ultrasound Sys
Indications for Use:
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiae, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S2000 510(k) Submission
Page 12 of 43
Huldeee
{5}------------------------------------------------
### 1.3 Indications for Use Forms
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (it known):
Device Name:
Intended Use:
ACUSON S2000 Ultrasound System
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Abdominal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Intraoperative<br>(Note 9) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Intraoperative<br>Neurological | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 |
| Pediatric | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Small Organ<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Cardiac | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10 |
| Trans-esophagea! | P | P | P | P | P | P | P | | BMDC | |
| Transrectal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Transvaginal | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,10,<br>11,14 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Musculo-skeletal<br>Superficial | P | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 |
| Other (specify)<br>Neonatal Cardiac | P | P | P | P | P | P | P | | BMDC | Note 3,4,6 |
N = new indication; P = previously cleared by FDA, K072786; E = added under Appendix E
Nota 1 For example: breast, testes, thyrold, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology 서에는 온 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic Imaging
Note 8 Power SieScape panoramic imaging
Note 9 For example: vascular, abdominal
Clarity VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear multi-view spatial compounding
Note 13 STIC
Note 13 \$TIC
Note 14 eSie™ Touch elasticity Imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.10
S2000 510(k) Submission
Page 13 of 43
Hulu Leem
(Division Sigh Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
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510 (k) Number (if known):
Device Name: CW2 Probe for use with ACUSON S2000 Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | | | | | | Mode of Operation | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | P | | | | | | |
| Abdominal | | | | | P | | | | | | |
| Intraoperative<br>(Note 9) | | | | P | P | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | P | | | | | | | |
| Small Organ<br>(Note 1) | | | | P | | | | | | | |
| Neonatal Cephalic | | | | P | | | | | | | |
| Adult Cephalic | | | | P | | | | | | | |
| Cardiac | | | | P | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | P | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | P | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | P | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063803, K072786; E = added under Appendix E
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
For example: vascular, abdominal
Nole 9
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 14 of 43
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{7}------------------------------------------------
510 (k) Number (if known);
CW5 Probe for use with ACUSON S2000
Device Name: Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | P | | | | | | |
| Abdominal | | | | | P | | | | | | |
| Intraoperative<br>(Note 9) | | | | | P | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | P | | | | | | |
| Small Organ<br>(Note 1) | | | | | P | | | | | | |
| Neonatal Cephalic | | | | | P | | | | | | |
| Adult Cephalic | | | | | P | | | | | | |
| Cardiac | | | | | P | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | P | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | P | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | P | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063803, K072786; E = added under Appendix E
Additional Comments:
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
Note 9 For example; vascular, abdominal
> (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 15 of 43
Hahn Leussen
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological De 510(k) Number
{8}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: EC9-4 Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, | |
| intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11,14 | |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5, 6, 7,8,10,<br>11,14 | |
| Transvaginal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N == new indication; P = previously cleared by FDA K# 053803, K072786; E = added under Appendix E
Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2
Ensemble tissue harmonic imaging Nota 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear multi-view spatial compounding Note 12
Note 14 eSie™ Touch elasticity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 16 of 43
Helmut Reem
(Division Sian-Off uctive. Abdominal and Radiological De 510(k) Number
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### Dlagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
Intended Use:
9L4 Linear Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11,14 |
| Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10, 11 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6, 7,8,10, 11,<br>14 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 |
| Musculo-skeletal<br>Superficial | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,6,7,8,10, 11, 14 |
| Other (specify) | | | | | | | | | | |
N = naw indication; P = previously cleared by FDA K# 063085, K072786; E = added under Appendix E
#### Additional Comments:
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding
Tissue Equalization Technology Note 3 Nole 4
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
B&W SleScape panoramic imaging Note 7
Note 8
Bower SieScape panoramic imaging
Clarify VE vascular enhancement technology Note 10
Note 11 Advanced Slectear multi-view spatial compounding
Nole 12
Note 14 eSie™ Touch elasticity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 17 of 43
Helene Demu
Division of Reproductive, Abdomin Radiological Di 510(k) Number
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name:
Intended Use:
4P1 Phased Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|-----------------------|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,6,7,8,10 | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063803, K072786; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi-view spatial compounding Note 4
Tissue Equalization Technology Note 5 3-Scape real-lime 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SiaScape panoramic Imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 19 of 43
Hulutem
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
{11}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
6C2 Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------------|--|
| | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 14 | |
| Intraoperative<br>Abdominal | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic Imaging
Note 3 SieClear multi-view spatial compounding
Note 4 Tissue Equalization Technology
3-Scape real-time 3D imaging
B&W SieScape panoramic imaging Nole 5 Note 7
Note B Power SieScape panoramic imaging
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compounding
Note 14 eSie™ Touch elasticity imaging
Note 14 eSia™ Touch elasticity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 20 of 43
Helsu Keen
(Division Sign-Off) Divi ision of Reproductive. Abdomin Radiolo 510(k) Number
{12}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
510 (k) Number (if known):
Device Name: Intended Use: 4C1 Curved Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| | | Mode of Operation | | | | | | | | |
|----------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|----------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note2,3,4,5,6,7,8,<br>10, 11, 14 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | P | P | P | P | P | | BMDC | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786, K032114; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
SieClear multi-view spatial compounding
TIssue Equalization Technology Note 3 Nolo 4
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic Imaging
Nole 8
Dow Stocope panoramic imaging
Power SieScape panoramic imaging
Clarity VE vascular enhancement technology Note 10
Advanced Sieclear multi-view spatial compounding Note 11
Note 12
Note 14 eSie™ Touch elasticity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 21 of 43
Herbert Linn
(Division Sign-Off) Division of Reproductive, Abdomina Radiological Device 510(k) Number
{13}------------------------------------------------
510 (k) Number (if known):
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Intended Use;
4V1 Phased Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|----------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>14 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786; E = Rdded under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging
Note 3 SieClear multi view spatial compounding
Tissue Equalization Technology Note 4 Note 5
3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
Note 10 Clarity VE vascular enhancoment technology
Note 11 Advanced Siectear multi-view spatial compounding
Note 14 eSie™ Touch elasticity imaging
> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
> > Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 22 of 43
Hecho
DIVIsion of Reproductive, Abdominal an 510(k) Number
{14}------------------------------------------------
510 (k) Number (if known):
Device Name: Intended Use:
10V4 Phased Array Transducer for use with ACUSON S2000 Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Abdominal | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | BMDC | Note 3,4 |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | P | P | P | P | P | P | | BMDC | Note 2,3,4,5,7,8,10 |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786; E = added under Appendix E
Additional Comments:
Note 2 Ensemble tissue harmonic imaging SieClear multI view spatial compounding
Note 3 Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 7 B&W Siescape panoramic imaging
Note 10 Clarity VE vascular enhancement technology
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 23 of 43
Hubert Lemmer
(Division Signature)
(Division Sigh-Off) Division of Reproductive, Abdomin Radiological Devices 510(k) Number
{15}------------------------------------------------
510 (k) Number (if known):
Device Name:
14L5 SP Linear Array Transducer for use with ACUSON S2000
Diagnostic imaging or fluid flow analysis of the human body as tollows: Indications For Use:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------------|--|--|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative<br>(Note 9) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10 | | |
| Intraoperative<br>Neurological | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11 | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral vessel | | P | P | P | | P | P | | BMDC | Note2,3,4,5,6<br>7,8,10, 11,14 | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,14 | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063085, K072786; E = added under Appendix E
Additional Comments:
For example: breast, tesles, thyroid, penis, prostate, etc. Note 1
Note 2 Ensemble tissue harmonic imaging Note 3
SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology
Note 5 3-Scape real-time 3D imaging
Note 6 Cadence contrast agent imaging
Note 7 B&W SieScape panoramic imaging
Note 8 Power SieScape panoramic imaging
For example: vascular, abdominal
Note 9
Note 10 Clarify VE vascular enhancement technology
Note 11 Advanced Sieclear multi-view spatial compounding
Note 14 usie™ Touch elasticity imaging
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
S2000 510(k) Submission
Page 24 of 43
Hubert Leem
(Division Sigh-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{16}------------------------------------------------
510 (k) Number (if known):
Device Name: 7CF2 Curved array mechanical 3D transducer for use with ACUSON \$2000 Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | P | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11,13 |
| Abdominal | | P | P | P | | P | P | | BMDC | Note 2,3,4,5,7,8,10,<br>11, 13 |
| Intraoperative<br>Abdominal | | | | | | | | | | |
| Intraoperative<br>Nourological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethrai | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skelatal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N = new indication; P = previously cleared by FDA K# 063803, K072786; E = added under Appendix E
Additional Comments:
Ensemble 1issue harmonic imaging
SieClear multi-view spatial compounding
Tissue Equalization Technology Note 2 Note 3
Note 4
Note 5 3-Scape real-time 3D imaging
Nota 7 B&W SieScape panoramic imaging
Note 8
Power SieScape panoramic imaging
Clarity VE vascular enhancement technology Note 10
Note 11 Advanced Sieclear multi-view spatial compounding
Note 13 STIC
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use {Per 21 CFR 801.109}
S2000 510(k) Submission
Page 25 of 43
vision Sign-Off) of Reproductive, Abdominal 510(k) Num
{17}------------------------------------------------
#### 510 (k) Number (if known):
Device Name: Intended Use: 9EVF4 Curved Array Transducer for use with ACU…
