SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
Device Facts
| Record ID | K142395 |
|---|---|
| Device Name | SC2000 and ACUSON X300 Diagnostic Ultrasound Systems |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product Code | IYO · Radiology |
| Decision Date | Sep 9, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal Intraoperative, Intraoperative, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging". The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Device Story
SC2000/X300 are multi-purpose, software-controlled diagnostic ultrasound systems; acquire primary/secondary harmonic ultrasound echo data; display in B-Mode, PW/CW Doppler, Color Doppler, Amplitude Doppler, 3D/4D imaging, and harmonic imaging. Systems use various transducers and catheters for intra-cardiac/intraluminal visualization. Operated by clinicians in clinical settings; provide anatomical measurements and analysis packages (e.g., Arterial Health Package for Intima Media Thickness). Output displayed on-screen for clinical diagnosis; supports ECG acquisition for image synchronization. Benefits include non-invasive visualization of anatomy/physiology and guidance during intraoperative procedures.
Clinical Evidence
No clinical data submitted. Substantial equivalence based on bench testing, including acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety testing per recognized standards (e.g., IEC 60601-1, IEC 60601-2-37).
Technological Characteristics
Mobile, software-controlled ultrasound systems; B-Mode, M-Mode, PW/CW Doppler, Color Doppler, 3D/4D imaging. Transducers/catheters for intra-cardiac/intraluminal use. Compliance with IEC 60601-1 (electrical safety), IEC 60601-2-37 (ultrasound safety), and ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in adult, pediatric, neonatal, and fetal patients across general radiology, cardiac, vascular, musculoskeletal, and intraoperative applications. Contraindications: None stated.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2014
Siemens Medical Solutions, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K142395
Trade/Device Name: SC2000/X300 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: August 21, 2014 Received: August 27, 2014
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the SC2000/X300 Diagnostic Ultrasound System, as described in your premarket notification:
| | SC2000 Transducer Model Number | | | | |
|------------|------------------------------------|-------|------|--|--|
| AcuNav 8F | Soundstar eco 8F | | 9L4 | | |
| 6C1HD | V5M | | 4V1c | | |
| 8V3 | CW2 | | 4Z1c | | |
| AcuNav 10F | ACUSON AcuNav™ V 10F SoundStar 10F | | | | |
| V7M | 10V4 | | | | |
| | X300 Transducer Model Number | | | | |
| AcuNav 8F | Soundstar eco 8F | P4-2 | | | |
| CH5-2 | VF10-5 | I 9-5 | | | |
| | | | | | |
{1}------------------------------------------------
| EC9-4 | EV9-4 | VF13-5 |
|-------|------------|---------------|
| P8-4 | BE 9-4 | CW2 |
| CW5 | AcuNav 10F | V5Ms |
| 4V1c | VF13-5SP | C8-5 |
| 8L3 | 10V4 | C7F2 |
| EV9F4 | L13F5 | VF8-3 |
| P5-1 | C6-2 | SoundStar 10F |
| P9-4 | | |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 does 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known): K142395
Device Name: ACUSON X300™ Diagnostic Ultrasound System SONOVISTA X300 Diagnostic Ultrasound System ACUSON X300 " Diagnostic Ultrasound System, premium edition
The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav and Soundstar Ultrsound Catheter are intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (21 CFG 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 1 of 31
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510(k) Number (if known):
Device Name: Intended Use: ACUSON X300 Diagnostic Ultrasound Systems
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Neuro) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-rectal | P | P | P | | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-vaginal | P | P | P | | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Convent.) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra -vascular | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other<br>(Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Cardiac Pediatric | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-esophageal<br>(Cardiac) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-Cardiac | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
N = new indication; P = previously cleared K080760, 121699
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 3 3D imaging
Power SieScape panoramic imaging Note 5
Contrast agent imaging Note 7
Note 9 Tissue Equalization Technology
Note 11 Dynamic TCE Note 2 Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
For example: abdominal, vascular Note 4
Note 6
SieClear multi-view spatial compounding Note 8
Note 10 Intracardiac imaging
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
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510(k) Number (if known):
AcuNav 8F Intracardiac Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems
Device Name: Intended Use:
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | |
|-----------------------------|------------------------------------------------------------|-------------------|---|-----|-----|------------------|------------------|-----------------------|---------------------|--|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal | Pediatric | | | | | | | | | |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | |
| | Intra-vascular | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Other<br>(Specify) | | | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
| | N = new indication; P = previously cleared K080760, 121699 | | | | | | | | | |
Note 1 state etc F olo: hr st testes thvroid i onic
| Note 1 | For example: breast, testes, thyroid, penis, prostate, etc. | Note 11 | syngo Arterial Health Package (AHP) |
|---------|-------------------------------------------------------------|---------|---------------------------------------------|
| Note 2 | Dynamic TCE Technology | Note 12 | syngo Auto OB Measurements |
| Note 3 | SieClear | Note 13 | syngo Auto Left Heart (Auto LH) Technology |
| Note 4 | Advanced SieClear | Note 14 | syngo Velocity Vector Imaging Technology |
| Note 5 | 3-Scape 3D Imaging | Note 15 | CartoSound Communication |
| Note 6 | For example: abdominal, vascular | Note 16 | Intracardiac Echocardiography (ICE) Imaging |
| Note 7 | Stress Echo Imaging | Note 17 | syngo fourSight TEE View |
| Note 8 | Axius Edge Assisted Ejection Fraction | Note 18 | syngo Mitral Valve Assessment (MVA) |
| Note 9 | Clarify Vascular Enhancement Technology | Note 19 | syngo fourSight 4D imaging |
| Note 10 | SieScape Panoramic Imaging | Note 20 | Contrast Agent Imaging |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)__
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510(k) Number (if known):
| Device Name: | Soundstar eco 8F Intracardiac Transducer for use with:<br>ACUSON X300 Diagnostic Ultrasound Systems |
|---------------|-----------------------------------------------------------------------------------------------------|
| Intended Use: | Diagnostic imaging or fluid flow analysis of the human body as follows: |
| Clinical Application | | | Mode of Operation | | | | | | | |
|-----------------------------|-------------------------------|---|-------------------|-----|-----|------------------|------------------|-----------------------|---------------------|--|
| Other<br>( Track1<br>Only) | Specific<br>(Tracks1& 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>Doppler | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | |
| | Fetal | | | | | | | | | |
| | Abdominal | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | |
| | Laparoscopic | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | |
| | Trans-rectal | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | |
| | Trans-urethral | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | |
| | Intra-vascular | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Other<br>(Specify) | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | |
| | Intra-cardiac | P | P | P | P | P | P | BMDC | Note 2,8,9,13,14,16 | |
| | Other (Specify) | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | |
| | Other (Specify) | | | | | | | | | |
N = new indication; P = previously cleared K080760, 121699
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 2 Dynamic TCE Technology
Note 3 SieClear
Advanced SieClear Note 4 Note 5 3-Scape 3D Imaging
For example: abdominal, vascular Note 6
Note 7 Stress Echo Imaging
Note 8 Axius Edge Assisted Ejection Fraction
Note 9 Clarify Vascular Enhancement Technology
Note 10 SieScape Panoramic Imaging
syngo fourSight TEE View Note 17 Note 18 syngo Mitral Valve Assessment (MVA)
Note 19 syngo fourSinght 4D imaging Note 20 Contrast Agent Imaging
syngo Arterial Health Package (AHP)
syngo Auto Left Heart (Auto LH) Technology
Intracardiac Echocardiography (ICE) Imaging
syngo Velocity Vector Imaging Technology
syngo Auto OB Measurements
CartoSound Communication
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Note 11
Note 12
Note 13
Note 14
Note 15
Note 16
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
{7}------------------------------------------------
510(k) Number (if known):
ACUSON X300 Diagnostic Ultrasound Systems
Device Name: Intended Use:
**ACUSON X300 Diagnostic Ultrasound Systems**
Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|--|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks11& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Abdominal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-operative<br>(Note 6) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-operative<br>(Neuro) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Laparoscopic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Fetal<br>Imaging<br>& Other | Pediatric | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | SmallOrgan<br>(Note 1) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Neonatal Cephalic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Adult Cephalic | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Trans-rectal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Trans-vaginal | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Trans-urethral | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Trans-esoph.<br>(non-Card.) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Musculo-skel.<br>(Convent.) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Musculo-skel.<br>(Superfic) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra -vascular | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Other<br>(Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Cardiac Adult | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Cardiac | Cardiac Pediatric | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-vascular<br>(Cardiac) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Trans-esophageal<br>(Cardiac) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Intra-Cardiac | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Other (Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
| | Other (Specify) | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 | |
N = new indication; P = previously cleared by K080760, 121699
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 3
Note 5 3D imaging
Power SieScape panoramic imaging Contrast agent imaging Note 7
Note 9 Tissue Equalization Technology
Note 11 Dynamic TCE
Note 2 Ensemble tissue harmonic imaging Note 4
Note 6 B&W SieScape panoramic imaging
For example: abdominal, vascular
te 6 For example: abdominal, vasc
Note 8 SieClear multi-view spatial compounding
Note 10 Intracardiac imaging
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 5 of 31
{8}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
P4-2 Phased Sector Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|--|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>( Track 1<br>Only) | Specific<br>(Tracks1& 3) | | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | | |
| | Fetal | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,5,6,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | | | | | | | | | | | |
| | Neonatal Cephalic | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-rectal | | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | | |
| Cardiac | Cardiac Adult | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Cardiac Pediatric | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | P | P | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | | | | | | | | | | | |
N = new indication; P = previously cleared by K080760, 121699
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 3 3D imaging
- Power SieScape panoramic imaging Note 5
- Contrast agent imaging
Tissue Equalization Technology Note 7
Note 9
- Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
- Note 8
Note 10
For example: abdominal, vascular SieClear multi-view spatial compounding
Intracardiac imaging
10 Intracardiac imaging
Note 2 Ensemble tissue harmonic imaging Note 4 B&W SieScape panoramic imaging Note 6
{9}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
CH5-2 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|---------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | | | |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | P | P | P | P | | P | P | | BMDC | Note<br>2.3.4.5.7.8.9,11 |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Cardiac | Cardiac Pediatric | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K080760, 121699
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 3 3D imaging
- Note 5 Power SieScape panoramic imaging
Contrast agent imaging
Tissue Equalization Technology Note 7
Note 9 Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Page 7 of 31
Note 6 For example: abdominal, vascular Note 8
Note 10
For example: abdominal,
SieClear multi-view spatial
SieClear multi-view spa
a Intracardiac imaging
SieClear multi-view spatial compounding
Intracardiac imaging
Steclear multi-view sp
0 Intracardiac imaging
Note 2 Ensemble tissue harmonic imaging Note 4 B&W SieScape panoramic imaging
{10}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
VF10-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------|---------------------------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Other (Specify) | | | | | | | | | | |
| | N = new indication; P = previously cleared by K080760, 121699 | | | | | | | | | | |
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
Note 3
3D imaging
Power SieScape panoramic imaging Note 5
Note 7 Contrast agent imaging
Note 9 Tissue Equalization Technology
Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)
Page 8 of 31
Note 4 B&W SieScape panoramic imaging Note 6 For example: abdominal, vascular Note 8
Note 2
SieClear multi-view spatial compounding Note 10 Intracardiac imaging
Ensemble tissue harmonic imaging
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
L9-5 Linear Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|----------------------------|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track 1<br>Only) | Specific<br>(Tracks 1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal | Pediatric | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Imaging<br>& Other | SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | | | | | | | | | |
| | Trans-vaginal | | | | | | | | | | |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Musculo-skel.<br>(Superfic) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-Cardaic | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral | Peripheral vessel | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| Vessel | Other (Specify) | | | | | | | | | | |
N = new indication; P = previously cleared by K080760, 121699
For example: breast, testes, thyroid, penis, prostate, etc. Note 1
- Note 3
3D imaging
Power SieScape panoramic imaging Note 5
Contrast agent imaging Note 7
Note 9 Tissue Equalization Technology
Dynamic TCE Note 11
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 510(k)_
Page 9 of 31
Note 4 B&W SieScape panoramic imaging Note 6
For example: abdominal, vascular
Ensemble tissue harmonic imaging
Note 8 SieClear multi-view spatial compounding
Note 10 Intracardiac imaging
Note 2
{12}------------------------------------------------
510(k) Number (if known):
Device Name: Intended Use:
EC9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|-----------------------------|---------------------------------------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1& 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | P | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric<br>SmallOrgan<br>(Note 1) | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Neonatal Cephalic | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Adult Cephalic | | | | | | | | | | |
| | Trans-rectal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-vaginal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Trans-urethral | | | | | | | | | | |
| | Trans-esoph.<br>(non-Card.) | | | | | | | | | | |
| | Musculo-skel.<br>(Convent.) | | | | | | | | | | |
| | Musculo-skel.<br>(Superfic) | | | | | | | | | | |
| | Intra-vascular | | | | | | | | | | |
| | Other<br>(Specify) | | | | | | | | | | |
| | Cardiac Adult | | | | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | | | | |
| | Intra-vascular<br>(Cardiac) | | | | | | | | | | |
| | Trans-esophageal<br>(Cardiac) | | | | | | | | | | |
| | Intra-Cardiac | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | | | |
| | Other (Specify) | | | | | | | | | | |
| | N = new indication; P = previously cleared by K080760, 121699 | | | | | | | | | | |
N = new indication, F = previously cleared by K060760, 121055
Note 1 For example: breast, testes, thyroid, penis, prostate, etc.
- Note 3 3D imaging
Power SieScape panoramic imaging Note 5
Note 7 Contrast agent imaging Note 9 Tissue Equalization Technology
- Note 11 Dynamic TCE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
510(k)_
Ensemble tissue harmonic imaging
B&W SieScape panoramic imaging
- For example: abdominal, vascular
SieClear multi-view spatial compounding Intracardiac imaging Note 10
- Note 2 Note 4 Note 6 Note 8
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
Intended Use:
EV9-4 Convex Array Transducer for use with: ACUSON X300 Diagnostic Ultrasound Systems Diagnostic imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | | | |
|-----------------------------|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Other<br>(Track1<br>Only) | Specific<br>(Tracks1 & 3) | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | | | | |
| | Fetal | | P | P | P | | P | P | | BMDC | Note<br>2,3,4,5,7,8,9,11 |
| | Abdominal | | | | | | | | | | |
| | Intra-operative<br>(Note 6) | | | | | | | | | | |
| | Intra-operative<br>(Neuro) | | | | | | | | | | |
| | Laparoscopic | | | | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatric | | | | | | | | | | |
| | SmallOrgan<br>(Note 1) | | P | P | P | | P | P…
