Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
Device Facts
| Record ID | K142323 |
|---|---|
| Device Name | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System |
| Applicant | Ge Medical Systems Israel , Ltd. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 10, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.
Device Story
Vivid S60/S70 is a mobile diagnostic ultrasound system for echocardiography, vascular, and general imaging. It uses electronic array transducers (phased, linear, curved, matrix, CW, 4D) to acquire, process, and display ultrasound data. Operated by physicians in clinical settings, the system features a 19-inch LCD and 12.1-inch touch panel. It performs B-mode, M-mode, Doppler (PW/CW/Color/Power), harmonic imaging, and real-time 3D/4D volume acquisition. Processing features include speckle reduction, tissue tracking, and automated functional imaging (AFI). Output is displayed on the integrated screen to assist clinicians in diagnostic evaluation and clinical decision-making, potentially improving patient management through enhanced visualization of anatomy and blood flow.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/mechanical safety testing in accordance with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, NEMA UD 2/3).
Technological Characteristics
Mobile console (56x77x120 cm) with 19-inch LCD and 12.1-inch touch panel. Supports phased, linear, curved, matrix, and CW transducers. Imaging modes: B, M, Color/Power Doppler, PW/CW Doppler, Harmonic, Coded Pulse, RT3D/4D. Connectivity: DICOM. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, ISO 10993-1, ISO 14971.
Indications for Use
Indicated for ultrasound evaluation of fetal/obstetrics, abdominal (renal/GYN), pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal, urology (prostate), and transesophageal applications in patients requiring diagnostic ultrasound imaging 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
- Vivid E9 Diagnostic Ultrasound System (K131514)
- Vivid S5/S6 Diagnostic Ultrasound System (K121063)
- 6VT-D Diagnostic Ultrasound Transducer (K141093)
- Logiq E9 Diagnostic Ultrasound System (K123564)
Related Devices
- K170878 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Jun 14, 2017
- K121063 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Aug 21, 2012
- K092079 — MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND · Ge Medical Systems Israel, Ultrasound, Ltd. · Aug 6, 2009
- K223832 — Vivid S60N, Vivid S70N · Ge Medical System Ultrasound and Primary Care Diagnostics · Feb 16, 2023
- K101149 — GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM · Ge Vingmed Ultrasound AS · Oct 13, 2010
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The profiles are arranged in a way that creates a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 10, 2014
GE MEDICAL SYSTEMS ISRAEL LTD. % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226
Re: K142323
Trade/Device Name: Vivid S60/S70 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: August 18, 2014 Received: August 20, 2014
Dear Mr. Behn:
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 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| 12S-D | 6S-D | P2D |
|--------|------------|--------|
| 9L-D | 6VT-D | C1-6-D |
| M5Sc-D | 6Tc/6Tc-RS | |
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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 (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.
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.
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.f)
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) K142323
Device Name
Vivid S60/S70 Diagnostic Ultrasound System
Indications for Use (Describe)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The frame has decorative swirls or flourishes around the perimeter. The logo is colored in a light blue hue.
## Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid S60/S70 system.
Combinations identified "P" for the transducers represents those previously cleared with another GE Ultrasound system.
Combinations identified ''N'' for the transducers represents those that are new.
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The logo is blue and white.
#### Diagnostic Ultrasound Indications for Use Form GE Vivid S60/S70 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | N |
| Abdominal [1] | N | N | N | N | N | N | N | N | N | N | N |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | N |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | N |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | N | N |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | N |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | N | N | N | N | N | N | N | N | N | N | N |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | N |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative [5] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
System provides real-time 3D and 4D acquisition when used with special 4D probes.
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The border has decorative flourishes resembling leaves or waves. The logo is colored in a light blue hue.
510(k) Premarket Notification Submission
### GE Vivid S60/S70 with 12S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|----------------|---------------------|----------------|---------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Small Organ | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[1] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K121063, K131514); E = added under Appendix E
Notes: [1] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ �] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
Page 3 of 10
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The border has decorative flourishes resembling leaves or waves. The logo is colored in a light blue hue.
510(k) Premarket Notification Submission
#### GE Vivid S60/S70 with 9L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
Page 4 of 10
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, surrounded by a circular frame with decorative elements. The logo is colored in a light blue hue, and the overall design is simple and recognizable.
510(k) Premarket Notification Submission
### GE Vivid S60/S70 with M5Sc-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|---------------|
| Clinical<br>Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The border has decorative flourishes resembling leaves or waves. The logo is colored in a light blue hue.
510(k) Premarket Notification Submission
### GE Vivid S60/S70 with 6S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[�] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has decorative, swirling elements around the letters, giving it a classic and recognizable appearance.
## GE Vivid S60/S70 with 6VT-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|---------------|
| Clinical Application<br>Anatomy/ Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K141093); E = added under Appendix E
Notes: [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, surrounded by a circular frame with decorative elements. The logo is colored in a light blue hue, and the overall design is simple and recognizable.
### GE Vivid S60/S70 with 6Tc/6Tc-RS Transducer **
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/ Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
|-----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K121063); E = added under Appendix E
Notes: [3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
[**] 6Tc differs from 6Tc-RS only in the connector type.
Page 8 of 10
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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in a blue color. The logo is simple and recognizable, representing the company's brand identity.
## GE Vivid S60/S70 with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Clinical Application<br>Anatomy/ Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | P | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K131514); E = added under Appendix E
Notes: [3] Cardiac is Adult and Pediatric.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
Page 9 of 10
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Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by decorative swirls or flourishes, also in blue, giving the logo a classic and recognizable appearance.
#### GE Vivid S60/S70 with C1-6-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Clinical<br>Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | P |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA (K123564); E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
- [4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
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Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The logo is colored in a light blue hue, and the background is white.
### 510(k) Summary
| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 18, 2014 |
| Submitter: | GE Healthcare<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare<br>T:(414)721-4214<br>F:(414)918-8275 |
| Alternate Contact Person: | Karin Shimoni<br>Regulatory Affairs Leader<br>GE Healthcare<br>T: +972-4-8519-619<br>F: +972-4-8519-500 |
| Device: Trade Name: | Vivid S60 and Vivid S70 Diagnostic Ultrasound System |
| Common/Usual Name: | Vivid S60, Vivid S70 |
| Classification Names: | Class II |
| | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN |
| Product Code: | Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K1315141 Vivid E9 Diagnostic Ultrasound System.<br>K121063 Vivid S5/S6 Diagnostic Ultrasound System.<br>K141093 6VT-D Diagnostic Ultrasound Transducer.<br>K123564 Logiq E9 Diagnostic Ultrasound System.…
