Vivid S60N, Vivid S70N
Device Facts
| Record ID | K170878 |
|---|---|
| Device Name | Vivid S60N, Vivid S70N |
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC |
| Product Code | IYN · Radiology |
| Decision Date | Jun 14, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrios; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cadiac (adult and pediatric); Peripheral Vasculo-sketal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.
Device Story
Vivid S60N/S70N is a mobile, console-based diagnostic ultrasound system for cardiac, vascular, and general radiology imaging. It utilizes electronic array transducers (linear, curved, sector/phased, matrix, dual) to acquire ultrasound signals. The system processes these signals to provide real-time 2D, 3D, and 4D imaging, Doppler analysis (PW, CW, Color, Power), and M-mode. Operated by physicians or qualified clinicians in clinical settings, the system displays images on an integrated LCD monitor. It includes automated analysis tools like 4D Auto MVO, 4D Auto AVQ, and Cardiac AutoDoppler to assist in quantification and workflow. Output is used for diagnostic assessment and interventional guidance. The device supports DICOM networking and wireless connectivity for image storage and printing. Benefits include enhanced diagnostic visualization and streamlined clinical workflows for cardiac and general imaging.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety testing, as well as module, integration, performance, and simulated use validation.
Technological Characteristics
Mobile console with height-adjustable control panel, color LCD touch panel, and LCD monitor. Transducers: linear, curved, sector/phased, matrix, dual, CW, and real-time 3D. Connectivity: LAN and wireless (USB-adapter). Standards: ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2/UD 3, ISO 10993-1, ISO 14971, DICOM. Biocompatible patient-contact materials.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal (renal/GYN/pelvic/aorto-iliac), pediatric, small organ (breast/testes/thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urology/prostate, transesophageal, transvaginal, transrectal, transurethral, intraoperative, intravascular, and intracardiac/intraluminal 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
- Vivid S60, Vivid S70 (K142323)
- Vivid E80, Vivid E90, Vivid E95 (K150087)
- Vivid iq (K161706)
- LOGIQ E9 (K163077)
- TomTec Arena TTA2 (K150122)
Related Devices
- K142323 — Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System · Ge Medical Systems Israel , Ltd. · Oct 10, 2014
- K223832 — Vivid S60N, Vivid S70N · Ge Medical System Ultrasound and Primary Care Diagnostics · Feb 16, 2023
- K121063 — VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Aug 21, 2012
- K150087 — Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System · Ge Vingmed Ultrasound AS · Mar 4, 2015
- K211216 — Vivid S60N / Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 9, 2021
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC June 14, 2017 TRACEY ORTIZ REGULATORY AFFAIRS DIRECTOR 9900 W. INNOVATION DRIVE WAUWATOSA, WI 53226
Re: K170878
Trade/Device Name: Vivid S60N. Vivid S70N Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, ITX, IYO Dated: May 15, 2017 Received: May 16, 2017
Dear Ms. Ortiz:
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.
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.
{1}------------------------------------------------
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.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
K170878
Device Name Vivid S60N, Vivid S70N
#### Indications for Use (Describe)
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis for the following applications: Fetal/Obstetrios; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cadiac (adult and pediatric); Peripheral Vasculo-sketal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transesophageal; Transvaginal; Transrectal; Intra-cardiac and Intra-luminal.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular border. The color of the logo is a light blue.
# Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid S60N / Vivid S70N. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
The following Indication for Use forms are appended:
Transducer: 3Sc-RS Transducer: M5Sc-D Transducer: 6S-D Transducer: 12S-D Transducer: 9L-D Transducer: 11L-D Transducer: C1-6-D Transducer: C2-9-D
System: Vivid S60N / Vivid S70N
- Transducer: C3-10-D
- Transducer: iC5-9-D
- Transducer: 6VT-D
- Transducer: 6Tc-RS
- Transducer: 9T-RS
- Transducer: P2D
- Transducer: P6D
- Transducer: AcuNav 10F (G version)
- Transducer: AcuNav 8F (G version)
- Transducer: SOUNDSTAR 3D 10F (G version)
- Transducer: SOUNDSTAR eco 8F (G version)
- Transducer: SOUNDSTAR eco 10F (G version)
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are four small white teardrop shapes around the letters. The logo is simple and recognizable, and it is associated with a well-known company.
### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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 | Other<br>[Notes] | |
| Ophthalmic | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | [8,9,1,2] | |
| Abdominal | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Small Organ | N | N | N | N | N | N | N | N | N | N | [3,8] | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | [,9] | |
| Cardiac | N | N | N | N | N | N | N | N | N | N | [4,6,9] | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [8,9] | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | [8] | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | [8] | |
| Other | N | N | N | N | N | N | N | N | N | N | [5,8,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | [6,9] | |
| Transrectal | N | N | N | N | N | N | N | N | N | N | [8] | |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | [8] | |
| Transuretheral | N | N | N | N | N | N | N | N | N | N | | |
| Intraoperative | N | N | N | N | N | N | N | N | N | N | | |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N | | |
| Intravascular | N | N | N | N | N | N | N | N | N | N | | |
| Interventional Guidance | N | N | N | N | N | N | N | N | N | N | | |
| Intracardiac and Intraluminal | N | N | N | N | N | N | N | N | N | N | [9] | |
| Tissue Biopsy | N | N | N | N | N | N | N | N | N | N | [7,8,9] | |
| Vascular Access (IV, PICC) | N | N | N | N | N | N | N | N | N | N | [8] | |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq
(K161706); N = New indication.
Notes: Abdominal includes renal, GYN/Pelvic [1]
[2] Abdominal includes Aorto-Iliac Artery
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate 151
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{5}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with C3-10-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 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | N | N | N | | N | N | N | N | N | N | [8,1] |
| Pediatric | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | [8] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | P1 | bl | P1 | | b1 | N | ь1 | ь1 | P1 | P1 | [8] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | [8] |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | N | N | N | [8] |
| Musculo-skeletal Superficial | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P1 | ь1 | P1 | | ь1 | N | ь1 | b1 | N | N | [7,8] |
| Vascular Access (IV, PICC) | P1 | P1 | P1 | | P1 | N | P1 | P1 | N | N | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [9]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [9,1] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [9] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [9] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | P | P | P | [4,9] |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [9] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Abdominal includes Aorto-Iliac Artery
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [9]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{7}------------------------------------------------
Image /page/7/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. There are four small, stylized flourishes or embellishments evenly spaced around the outside of the circle. The logo is rendered in a blue color.
### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with IC5-9-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 | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P2 | P2 | P2 | | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
| Abdominal | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | P2 | P2 | P2 | | P2 | P2 | P2 | P2 | P2 | P2 | [5,8] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P2 | P2 | P2 | | P2 | P2 | P2 | P2 | N | P2 | [8] | |
| Transvaginal | P2 | P2 | P2 | | P2 | P2 | P2 | P2 | N | P2 | [8] | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy | P2 | P2 | P2 | | P2 | P2 | P2 | P2 | N | P2 | [7,8] | |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | | P2 | P2 | P2 | P2 | N | P2 | [8] | |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid ig (K161706); N = New indication.
Notes: [1] Abdominal includes renal, GYN/Pelvic
Abdominal includes Aorto-Iliac Artery (2
- [3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric. [4]
[5] Other use includes Urology/Prostate
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M. B/Color M. B/PWD. B/Color/PWD. B/Power/PWD 181
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD 191
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
### GE Vivid S60N / Vivid S70N with C2-9-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 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
| Abdominal | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [1,8,2] |
| Pediatric | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [5,8] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [7,8] |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Abdominal includes renal, GYN/Pelvic Notes: [1]
[2] Abdominal includes Aorto-Iliac Artery
- [3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
- Other use includes Urology/Prostate [5]
- 3D/4D Imaging mode 161
- [7] Includes image quidance for freehand needle placement
- [8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
- Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N 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 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8,1] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [8] |
| Small Organ | P | P | P | P | P | P | P | P | P | P | [3,8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [7,8] |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. The circle is decorated with small, stylized floral or leaf-like shapes around its perimeter, giving it a distinctive and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 11L-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 | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Pediatric | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
| Small Organ | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [3,8] | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
| Musculo-skeletal Conventional | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | [8] | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [7,8] | |
| Vascular Access (IV, PICC) | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] | |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized script inside. The circle has a decorative border with four teardrop-shaped elements around the perimeter. The logo is simple and recognizable, representing the well-known multinational corporation.
#### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with M5Sc-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 | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [9] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1,2,9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [9] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [9] |
| Cardiac | P | P | P | P | P | P | P | P | P | P | [4,9] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [9] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | P | P | P | P | P | P | P | P | P | P | [5,9] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [9] |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
P = previously cleared by FDA on Vivid S60 (K142323); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid E90/Vivid E95 (K150087); P3 = previously cleared by FDA on Vivid iq (K161706); N = New indication.
Notes: Abdominal includes renal. GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
Cardiac is Adult and Pediatric. [4]
Other use includes Urology/Prostate ાં છે.
[6] 3D/4D Imaging mode
[7] Includes image guidance for freehand needle placement
[8] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a shade of blue, and the background is white.
### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with 3Sc-RS 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 | Modes | Combined Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [9] |
| Abdominal | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [1,2,9] |
| Pediatric | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [9] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | N | [a] |
| Cardiac | P3 | P3 | P3 | P3 | P3 | ьз | P3 | P3 | P3 | N | [4,9] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [a] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P3 | P3 | N | P3 | N | P3 | P3 | P3 | P3 | N | [9] |
| Vascular Access (IV, PICC) | | | | | | | | | | |…
