S6 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K112602 |
|---|---|
| Device Name | S6 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | Sonoscape Company Limited |
| Product Code | IYN · Radiology |
| Decision Date | Nov 7, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The SonoScape S6 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Device Story
S6 Diagnostic Ultrasound System is an integrated, all-digital, software-controlled color ultrasound imaging system. It acquires ultrasound data via various transducers (phased, curved, micro-curved, linear arrays) and displays images in B-Mode (including Tissue Harmonic Imaging), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler, Power Doppler, and 3D/4D modes. Used in clinical settings by qualified physicians for diagnostic imaging and fluid flow analysis. The system features progressive dynamic receive focusing and exam-dependent default settings to enhance diagnostic utility. Output is displayed on the system monitor for real-time clinical evaluation, aiding in diagnosis and patient management across multiple medical specialties.
Clinical Evidence
Bench testing only. The device was evaluated for design specifications, acoustic output, thermal/mechanical/electrical safety, and biocompatibility. No clinical data was required or provided.
Technological Characteristics
All-digital architecture with progressive dynamic receive focusing. Supports B, M, PWD, CWD, Color Doppler, Power Doppler, 3D/4D, and Tissue Harmonic Imaging. Transducers: Phased, Curved, Micro-curved, and Linear arrays. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-5, ISO 10993-10.
Indications for Use
Indicated for qualified physicians to perform diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), cephalic (neonatal/adult), trans-rectal, trans-vaginal, peripheral vascular, musculoskeletal (conventional/superficial), cardiac (neonatal/adult), OB/Gyn, and urology applications.
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
- S20 Digital Doppler Ultrasound System and Transducers (K110510)
Submission Summary (Full Text)
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K112602
NOV - 7 2011
### Tab 21 PREMARKET NOTIFICATION 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
#### Manufacturer:
SonoScape Company Limited
Address: 4/F., Yizhe Building, Yuquan Road,Nanshan, Shenzhen 518051, P.R.China
Tel: (86) 755-26722890
Fax: (86) 755-26722850
Contact Person: Chen Zhiqiang
Date Prepared: August 31, 2011
#### Name of the device:
* Trade/Proprietary Name:
S6 Diagnostic Ultrasound System
* Common Name: Diagnostic Ultrasound System and Transducers
* Classification:
Regulatory Class: II
Review Category: Tier II
- 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
- 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO)
- 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
#### Legally Marketed Predicate Device:
S20 Digital Doppler Ultrasound System and Transducers -K110510
### Device Description:
The SonoScape S6 Diagnostic Ultrasound System is an integrated preprogrammed
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SonoScape Company LTD
color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features.
This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
#### Intended Use:
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
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#### Probe Information:
| No. | Probe | Type | Frequency Range | Intended Use |
|-----|-------|-----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------|
| 1 | 2P1 | Phased Array | 2.0-4.0 MHz | Abdominal<br>Neonatal Cephalic<br>Adult Cephalic<br>Cardiac Adult<br>Cardiac Pediatric |
| 2 | 5P1 | Phased Array | 3.0-7.0 MHz | Pediatric<br>Neonatal Cephalic<br>Cardiac Pediatric |
| 3 | 6V1 | Micro-curved<br>Array | 4.0-8.0 MHz | Trans-rectal<br>Trans-vaginal |
| 4 | 6V3 | Micro-curved<br>Array | 5.0-9.0 MHz | Trans-rectal<br>Trans-vaginal |
| 5 | EC9-5 | Micro-curved<br>Array | 5.0-9.0 MHz | Trans-rectal<br>Trans-vaginal |
| 6 | C611 | Micro-curved<br>Array | 4.0-8.0 MHz | Abdominal<br>Pediatric<br>Neonatal Cephalic<br>Cardiac Pediatric |
| 7 | C344 | Curved Array | 2.0-5.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 8 | C362 | Curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 9 | VC6-2 | Curved Array | 2.0-6.0 MHz | Fetal / Abdominal/ Ob/GYN |
| 10 | L741 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid, testes )<br>Musculo-skeletal (Conventional)<br>Peripheral vessel |
| 11 | L742 | Linear Array | 5.0-12.0 MHz | Small Organ (reast, thyroid, testes )<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Peripheral vessel |
| 12 | L743 | Linear Array | 5.0-10.0 MHz | Small Organ (reast, thyroid, testes )<br>Musculo-skeletal (Conventional)<br>Musculo-skeletal (Superficial)<br>Peripheral vessel |
#### Tab 21.1 Probe information
#### Safety Considerations:
The S6 Diagnostic Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device. The device has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 9, 2008. The acoustic output is measured and calculated per
Premarket Notification 510(k) Summary
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NEMA UD 2: 2004 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment and NEMA UD3: 2004 Standards for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment. The device conforms to applicable medical device safety standards, such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-5 and ISO 10993-10.
#### Testing:
Laboratory testing was conducted to verify that the S6 Diagnostic Ultrasound System with added transducer met all design specification and was substantially equivalent to the currently marketed Predicate Device as above. The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety as well as biocompatibility. Acoustic output is measured and calculated according to "Acoustic Output Measuring Standard for Diagnostic Ultrasound Equipment".
| Tab 21.2 Applicable Safety Standards | |
|--------------------------------------|--|
|--------------------------------------|--|
| Standards No. | Standards Title | Version | Date |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------|
| IEC 60601-1 | IEC 60601-1, Medical Electrical Equipment - Part 1:<br>General Requirements for Safety, 1988; Amendment<br>1, 1991-11, Amendment 2, 1995. | 1988 | 10/31/2005 |
| IEC 60601-1-2 | IEC 60601-1-2, (Second Edition, 2001), Medical<br>Electrical Equipment - Part 1-2: General<br>Requirements for Safety - Collateral Standard:<br>Electromagnetic Compatibility -- Requirements and<br>Tests. | 2007 | 07/31/2008 |
| IEC<br>60601-2-37 | IEC 60601-2-37 (2004) (2005) Amendment 2,<br>Medical electrical equipment - Part 2-37: Particular<br>requirements for the basic safety and essential<br>performance of ultrasonic medical diagnostic and<br>monitoring equipment. | 2007 | 09/08/2009 |
| NEMA UD 2 | NEMA UD 2-2004, Acoustic Output Measurement<br>Standard for Diagnostic Ultrasound Equipment<br>Version 3. | 2004 | 09/08/2009 |
| ISO 10993-5 | ISO 10993-5:1999, Biological evaluation of medical<br>devices -- Part 5: Tests for In Vitro cytotoxicity. | 2009 | 09/12/2007 |
| ISO 10993-10 | ISO 10993-10:2002, Biological evaluation of medical<br>devices - Part 10: Tests for irritation and delayed-type<br>hypersensitivity. | 2002 | 09/12/2007 |
Premarket Notification 510(k) Summary
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### Conclusion:
The conclusions drawn from testing of the S6 Diagnostic Ultrasound System with transducer demonstrate that the device is as safe and effective as the legally marketed predicate devices.
:
.
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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV - 7 2011
SonoScape Company Limited % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai, 200237 CHINA
Re: K112602
Trade/Device Name: S6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 6, 2011 Received: September 7, 2011
Dear Ms. Hong:
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 prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the S6 Diagnostic Ultrasound System, as described in your premarket notification: 1
Transducer Model Number
2P1 Phased Array 5P1 Phased Array 6V1 Micro-curved Array 6V3 Micro-curved Array EC9-5 Micro-curved Array C611 Micro-curved Array C362 Curved Array C344 Curved Array
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VC6-2 Curved Array L743 Linear Array L741 Linear Array L742 Linear 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 895. 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours.
Mary Stott
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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# 4.4 Tab 3 Indications For Use
510(k) Number:
Device Name:
S6 Diagnostic Ultrasound System
Indications for Use:
The SonoScape S6 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Patil
Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K112602
Indications For Use
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#### System: SonoScape S6 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|----------------------------------------------------------------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Small Organ (specify) | N | N | N | | N | N | Note 1 | Notes 2,4,6 |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Musculo-skeletal<br>(Superficial) | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Intravascular | | | | | | | | |
| Cardiac | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2,4,5 |
| | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | ר | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Other (specify) | | | | | | | | |
| N = new indication;<br>P = previously cleared by FDA:<br>E = added under this appendit | | | | | | | | | |
P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Note 5: 4D
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
Mary S. Patil
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112602
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Transducer: 2P1 Phase Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/TH; MC; B/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Note 5: 4D
Over-The-Counter Use (21 CFR 807 Subpart C)
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
May S. Pisto
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Di tic Device Evaluation and Safety
K112602
510K
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Transducer: 5P1 Phase Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|--------------------------------|---|-----|-----|------------------|---------------------------------|-------------------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Adult. Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
| N = new indication: | | P = previously cleared by FDA: | | | | | | E = added under this appendix | |
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler; W/C / P/aper Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: TIDI Note 4: 3D Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
May Slatte
(Division Sign Off)
Office of Ir
510K K112602
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#### Transducer: 6V1 Micro-curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | |
|----------------------------------------------------------------------------------------|------------------------------------|---|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal. | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
| N = new indication;<br>P = previously cleared by FDA;<br>F = added under this appendix | | | | | | | | | |
Note 1: Other Combined includes: BM proved in viri.
Note in Bernined includes: BMM; B/PWD; B/THI; M/Color M ; B/Color Doppler; B/Color Doppler; B/Color Doppler; W/D; B/Pover appendi Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 5: 4D
Note 3: TDI Note 4: 31)
Note 6: Small Organ: breast, thyroid, testes
Prescription Use *X*
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
Mary S/Patel
(Division Sign Off)
(Division Sign-C Division of Radiological Dev Office of In gnostic Device Evaluation and Safety
510K K112602
{12}------------------------------------------------
#### Transducer: 6V3 Micro-curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
N = new indication;
P == previously cleared by FDA;
E == added under this appendix
Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents Note 3: T`DI Note 4: 3D
Note 5: 4D
Note 6: Small Organ: breast, thyroid, testes
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
Mary S. Postel
(Divide Dir., OPS)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112602
{13}------------------------------------------------
#### Transducer: EC9-5 Micro-curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | | | | | | | | |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-vaginal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
N = new indication;
P = previously cleared by FDA;
E = added under this appendix
Note 1: Other Combined includes: BM; B/W/D; B/TH| M/Color Doppler: B/Color Doppler: B/Color Dopper/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Note 5: 41)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
EICH
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
Mary Potts
(Division Sign-Off)
Division of Radiological Devic Office of In fitro Diagnostic Device Evaluat on and Safety
{14}------------------------------------------------
Transducer: C611 Micro-curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | <b>B</b> | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletai<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | N | N | N | N | N | N | Note 1 | Notes 2,3,4 |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: BMF production of : B/Color Doppler, B/Color Doppler, B/Color Doppler, B/Color Doppler, B/Color Doppler, B/Color Doppler, B/Color Doppler, B/ Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Note 5: 4D
Over-The-Counter Use (21 CFR 807 Subpart C)
# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
.
Mary S. Petty
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devic Office of In tro Diagnostic Device Evaluation and Safety
510K K112602
{15}------------------------------------------------
Transducer: C362 Curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|--------------------------------|---------------------------------|-------------------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging &<br>Other | Fetal | N | N | N | | N | N | Note 1 | Notes 2,4 |
| | Abdominal | N | N | N | | N | N | Note1 | Notes 2,4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeletal<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2,4 |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph.(Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| | Other (specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | | |
| | Other (specify) | | | | | | | | |
| N = new indication; | | | | | | P = previously cleared by FDA: | | E = added under this appendix | |
P = previously cleared by FDA; E = added under this appendix Note 1: Other Combined includes: B/M; B/PWD; B/THI; M/Color Doppler; B/Color Doppler/PWD; B/Power Doppler/PWD
Note 2: Tissue Harmonic Imaging. The feature does not use contrast agents
Note 3: TDI Note 4: 3D
Note 6: Small Organ: breast, thyroid, testes
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Note 5: 4D
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Indications For Use
Mary S. Lath
(Division Sign-Off)
Division of Radiologic Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112602
{16}------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
#### Transducer: C344 Curved Array Diagnostic Ultrasound Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | | Mode of Operation | | | | | | | |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------------|--------------------|-------------------|
| General<br>(TRACK 1<br>ONLY) | Specific<br>(TRACKS 1 & 3) | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Other*<br>Combined | Other*<br>Specify |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal<br>Imaging&<br>Other | Fetal | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| | Abdominal | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| | Intra-operative Specify | | | | | | | | |
| | Intra-operative Neuro | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (specify) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph.(non-Card) | | | | | | | | |
| | Musculo-skeletal<br>(Conventional) | | | | | | | | |
| | Musculo-skeleta!<br>(Superficial) | | | | | | | | |
| | Intravascular | | | | | | | | |
| Cardiac | Other (Ob/GYN) | N | N | N | | N | N | Note 1 | Notes 2, 4 |
| | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular(Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |…
