Vivid S60N, Vivid S70N
Device Facts
| Record ID | K182450 |
|---|---|
| Device Name | Vivid S60N, Vivid S70N |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Oct 19, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for 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/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transvaginal; Transrectal; Intra-cardiac; Intra-luminal and Intraoperative (abdominal, thoracic, & vascular).
Device Story
Mobile diagnostic ultrasound system for cardiac, vascular, and general radiology imaging. Inputs: ultrasound signals from electronic array transducers (linear, curved, sector/phased, matrix, dual array, CW, 4D). Processing: cSound 2.0 software platform for digital acquisition, signal processing, and analysis. Outputs: real-time 2D/4D images, flow analysis, and measurements displayed on integrated monitor. Used in clinical settings by physicians/technicians. Features include 4D Marker for manual annotation, AFI 2.0/AutoEF for cardiac analysis, Z-score calculations, and Stream Server for real-time remote data streaming via LAN/WLAN. Connectivity: DICOM, Tricefy Cloud uplink, and wireless LAN. Cybersecurity: Windows 10 Embedded OS with whitelisting. Benefits: enhanced diagnostic visualization, workflow automation, and remote data access.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, thermal/electrical/mechanical safety, and software verification.
Technological Characteristics
Mobile console with height-adjustable control panel, LCD touch panel, and monitor. Transducers: linear, curved, sector/phased, matrix, dual array, CW, and 4D. Connectivity: LAN, wireless LAN (USB adapter), DICOM. Software: cSound 2.0 platform, Windows 10 Embedded OS. Cybersecurity: Whitelisting. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 62359, ISO 14971, NEMA PS3.1-3.20.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transesophageal, transvaginal, transrectal, intracardiac, intraluminal, and intraoperative applications. Intended for use by or under the direction of a qualified physician.
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
Submission Summary (Full Text)
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October 19, 2018
GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA, WI 53226
Re: K182450
Trade/Device Name: Vivid S60N, Vivid S70N Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 6, 2018 Received: September 7, 2018
Dear Tracey 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Hse 2. Mild
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known)
K182450
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/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transvaginal; Transrectal; Intra-cardiac; Intra-luminal and Intraoperative (abdominal, thoracic, & vascular).
| Type of Use (Select one or both, as applicable) | <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters and the edge of the circle. The logo is simple and recognizable, and it is associated with a well-known and established company.
# 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 as "P" represent those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
### The following Indication for Use forms are appended:
System: Vivid S60N / Vivid S70N Transducer: 3Sc-RS Transducer: 6S-D Transducer: 12S-D Transducer: 9L-D Transducer: 11L-D Transducer: L8-18i-D Transducer: C1-6-D Transducer: C1-5-D Transducer: C2-9-D Transducer: C3-10-D Transducer: iC5-9-D Transducer: 6VT-D Transducer: 6Tc-RS Transducer: 9T-RS Transducer: 10T-D Transducer: P2D Transducer: P6D Transducer: M5Sc-D (only on Vivid S70N) 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)
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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 script, enclosed within a circular frame. The frame is decorated with curved, teardrop-shaped elements, giving it a distinctive and recognizable appearance. The logo is presented in a blue color scheme.
#### 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 | P | P | P | P | P | P | P | P | P | P | [8,9] |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [8,9,1,2] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [8,9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [8,9] |
| Small Organ | P | P | P | P | P | P | P | P | P | P | [3,8] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [8,9] |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [9] |
| Cardiac | P | P | P | P | P | P | P | P | P | P | [4,6,9] |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8,9] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [8] |
| Other | P | P | P | P | P | P | P | P | P | P | [5,8,9] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | [6,9] |
| Transrectal | P | P | P | P | P | P | P | P | P | P | [8] |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [8] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | N | N | N | N | N | N | N | N | N | N | [10] |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | P | P | P | P | P | P | P | P | P | P | [9] |
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [7,8,9] |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K16307); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; .
Notes: Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Arterv [2]
Small organ includes breast, testes, thyroid. (3)
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate [5]
[6] 3D/4D Imaging mode
Includes image guidance for freehand needle placement [7]
[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]
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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)
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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, cursive font, enclosed within a blue circle. Four decorative, teardrop-shaped elements are spaced evenly around the outside of the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and represents the well-known multinational conglomerate.
#### 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 | P | P | P | | P | P | P | P | P | P | [8,1] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [8] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | [8] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;
[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
[6] 3D/4D Imaging mode
Notes:
Includes image guidance for freehand needle placement [7]
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
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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)
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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, cursive font, enclosed within a blue circle. Four decorative, teardrop-shaped elements are spaced evenly around the outside of the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and represents the well-known multinational conglomerate.
#### 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 | P | P | P | P | P | P | P | P | P | P | [9,1] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | |
| 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 S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;
[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
[6] 3D/4D Imaging mode
Notes:
[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
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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)
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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' written in a stylized script, enclosed within a blue circle. The circle has decorative elements resembling stylized lightning bolts or arcs around its perimeter.
### 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 | 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] |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [8] |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | P | P | P | P | P | P | P | P | P | P | [5,8] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | [8] |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [8] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [7,8] |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;
Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
- [3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric
ાંકા Other use includes Urology/Prostate
[6] 3D/4D Imaging mode
Notes:
[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 al
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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 logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script font in the center. There are also some wave-like designs around the letters. The logo is simple and recognizable, and it is often used to represent the company's brand.
### 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 | P | P | P | P | P | P | P | P | P | P | [8] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1,8,2] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [8] |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | P | P | P | P | P | P | P | P | P | P | [5,8] |
| 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 | [7,8] |
| Vascular Access (IV PICC) | P | P | P | P | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;
Abdominal includes renal, GYN/Pelvic [1]
Abdominal includes Aorto-Iliac Artery [2]
[3] Small organ includes breast, testes, thyroid.
[4] Cardiac is Adult and Pediatric.
ાંકી Other use includes Urology/Prostate
3D/4D Imaging mode ાંદા
Notes:
Includes image quidance for freehand needle placement [7]
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]
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, and there are white accents around the perimeter of the circle, giving it a three-dimensional 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 | P | P | P | | P | P | P | P | P | P | [8,1] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [8] |
| Small Organ | 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 | [8] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [8] |
| Other | | | | | | | | | | | |
| 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 | [7,8] |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 =
previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes: [1] Abdominal includes renal. GYN/Pelvic
1. Abdominal includes renal, GYN/Pelvic
2. Abdominal includes Aorta, Iliac Artery
Abdominal includes Aorto-Iliac Artery (21
[3] Small organ includes breast, testes, thyroid.
Cardiac is Adult and Pediatric [4]
151 Other use includes Urology/Prostate
[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 ાં છો
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, and there are white accents around the perimeter of the circle, giving it a three-dimensional 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 | P | P | P | | P | P | P | P | P | P | [8] |
| Small Organ | 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 | [8] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K173341); P2 = previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication;
[1] Abdominal includes renal, GYN/Pelvic
Abdominal includes Aorto-Iliac Artery [2]
- Small organ includes breast, testes, thyroid. [3]
[4] Cardiac is Adult and Pediatric.
Other use includes Urology/Prostate [5]
।ମା 3D/4D Imaging mode
Notes:
[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]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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 consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance.
#### Diagnostic Ultrasound Indications for Use Form GE Vivid S60N / Vivid S70N with L8-18i-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 | | | | | | | | | | | |
| Small Organ | P1 | P1 | P1 | | P1 | P1 | P1 | P1 | P1 | P1 | [2,8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P1 | P1 | P1 | | P1 | P1 | P1 | P1 | P1 | P1 | [8] |
| Musculo-skeletal Conventional | P1 | P1 | P1 | | P1 | P1 | P1 | P1 | P1 | P1 | [8] |
| Musculo-skeletal Superficial | P1 | P1 | P1 | | P1 | P1 | P1 | P1 | P1 | P1 | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P1 | P1 | P1 | | P1 | P1 | P1 | P1 | P1 | P1 | [10,8] |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy | | | | | | | | | | | |
| Vascular Access (IV. PICC) | | | | | | | | | | | |
P = previously cleared by FDA on Vivid S70N (K170878); P1 = previously cleared by FDA on Vivid E95 (K17341); P2 =
previously cleared by FDA on LOGIQ E9 (K163077); P3 = added under Appendix E based on Vivid E95 (K173341); N = New indication; Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Abdominal includes Aorto-Iliac Artery
Small organ includes breast, testes, thyroid. [3]
[4] Cardiac is Adult and Pediatric.
ાંકા Other use includes Urology/Prostate
[6] 3D/4D Imaging mode
Includes image guidance for freehand needle placement [7]
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
[10] Intraoperative includes abdominal, thoracic (including cardiac), and vascular (including PV)
System may provide 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 'GE' intertwined in a stylized script, enclosed within a circular frame. The frame has a pattern of stylized swirls or petals around the edge. The logo is colored in a light blue hue.
### 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 | 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 | 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…
