Vivid iq

K181727 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Dec 6, 2018 · Radiology

Device Facts

• Record ID: K181727
• Device Name: Vivid iq
• Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
• Product Code: IYN · Radiology
• Decision Date: Dec 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.

Device Story

Vivid iq is a compact, high-performance ultrasound system for cardiovascular and shared services. It acquires ultrasound signals via various transducers to produce B-mode, M-mode, PW/CW Doppler, Color Doppler, Color M, PDI, and harmonic imaging. Used in clinical settings by healthcare professionals for diagnostic imaging and fluid flow analysis. Features include 4D markers for annotation, Tricefy/Qview for cloud-based archiving/collaboration, QuickApps for parameter optimization, View-X for live video streaming from other modalities, and FlexiViews for 4D TEE. Output is displayed for clinical review, supporting diagnosis and interventional guidance. Benefits include improved ergonomic design, advanced connectivity, and productivity tools for cardiovascular labs.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench-level verification and validation testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/electromagnetic/mechanical safety testing. Usability testing with representative users was performed.

Technological Characteristics

Compact ultrasound system; supports B, M, PW/CW Doppler, Color Doppler, Color M, PDI, and harmonic imaging. Connectivity via DICOM, Tricefy (cloud), and Qpath/Qview. Biocompatible patient-contact materials. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, and NEMA UD 2.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, obstetric, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal, transcranial, transrectal, transvaginal, transesophageal, intraoperative, and intracardiac/intraluminal applications. Includes image guidance for freehand needle placement.

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 iq (K161706)
• Vivid E95 (K170823)
• Venue (K180599)
• Vscan Extend (K161588)
• LOGIQ e (K151028)
• Vivid T8 (K160078)
• LOGIQ P9 (K163596)
• LOGIQ P7 (K163596)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked above the words "U.S. FOOD & DRUG ADMINISTRATION".

December 6, 2018

GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA, WI 53226

Re: K181727

Trade/Device Name: Vivid iq Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 2, 2018 Received: November 5, 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/cfpmn/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.

{1}------------------------------------------------

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 and Part 809); 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.html; 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Hse 2. Mild

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}------------------------------------------------

### Indications for Use

510(k) Number K181727

Device Name Vivid iq

#### Indications for Use (Describe)

The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vasculo-sketal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.

Type of Use (Select one or both, as applicable)

| <span></span> <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|
|--------------------------------------------------------------------------|-------------------------------------------------------------------------|

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 blue circle. The circle has decorative flourishes around its perimeter, giving it a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

### Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid iq. 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:

System: Vivid iq Transducer: 3Sc-RS Transducer: M5Sc-RS Transducer: 6S-RS Transducer: 12S-RS Transducer: 6Tc-RS Transducer: 6VT-D Transducer: P2D Transducer: 9T-RS 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) Transducer: 9L-RS Transducer: 12L-RS Transducer: ML6-15-RS Transducer: L8-18i-RS Transducer: 4C-RS Transducer: C1-5-RS Transducer: E8Cs-RS Transducer: 8C-RS

{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 a stylized font in the center. The letters are connected and have a flowing, cursive appearance. The circle is surrounded by a decorative, swirling pattern, also in blue, which gives the logo a classic and recognizable look.

GE Healthcare 510(k) Premarket Notification Submission

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ [2] | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | 6 |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | P | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | 6 |
| Transrectal | P | P | P | P | P | P | P | P | P | P | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | |
| Intraoperative [4] | P | P | P | P | P | P | P | P | P | P | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | P | P | P | P | P | P | P | P | P | | |
| Tissue Biopsy[5] | P | | | | N | | P | | P | | |

### GE Vivid iq Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N= new indication; P= previously cleared by FDA K161706; P = previously cleared by FDA K151028. P = previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac is Adult and Pediatric;
- [4] Intraoperative includes thoracic(cardiac) and vascular (PV);
- [5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

- [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD
- [**] Coded Pulse is for digitally encoded harmonics.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a decorative, swirling pattern around the edges. The logo is colored in a shade of blue.

GE Healthcare 510(k) Premarket Notification Submission

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | 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 | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | P | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | P | | | P1 | | P | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |

#### GE Vivid iq with 3Sc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N= new indication; P= previously cleared by FDA K161706; P1= previously cleared by FDA K151028. P= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

Notes: [1] Abdominal includes GYN and Urological;

- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

- [5] Includes image guidance for freehand needle placement
[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

### GE Healthcare 510(k) Premarket Notification Submission

| Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|---|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | Combined<br>Modes[*] | P | | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | 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 | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | P | | | | P | | P | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |

### GE Vivid iq with M5Sc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N= new indication; P= previously cleared by FDA K161706; P = previously cleared by FDA K151028. P = previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{7}------------------------------------------------

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, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle.

510(k) Premarket Notification Submission

### GE Vivid iq with 6S-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 | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a decorative, swirling pattern around the edges. The logo is colored in a shade of blue.

GE Healthcare 510(k) Premarket Notification Submission

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|----|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P2 | P2 | P2 | P2 | P2 | P2 | | P2 | P2 | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | |
| Vascular Access (IV. PICC.) | | | | | | | | | | | |

#### GE Vivid iq with 12S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N= new indication; P= previously cleared by FDA K161706; P1= previously cleared by FDA K151028. P= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

Notes: [1] Abdominal includes GYN and Urological;

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle.

510(k) Premarket Notification Submission

### GE Vivid iq with 6Tc-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 | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV. PICC) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{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, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

510(k) Premarket Notification Submission

### GE Vivid iq 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 | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | 6 |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | | 6 |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{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, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle.

510(k) Premarket Notification Submission

### GE Vivid iq 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 | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | P | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{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, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

510(k) Premarket Notification Submission

### GE Vivid iq with 9T-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 | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{13}------------------------------------------------

Image /page/13/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. There are also three curved lines that surround the circle.

510(k) Premarket Notification Submission

### GE Vivid iq with AcuNav 10F (G version) 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 | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | P | P | P | P | P | P | P | P | P | P | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | P | P | P | P | P | P | P | P | P | P | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes thoracic(cardiac) and vascular (PV);

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD

{14}------------------------------------------------

Image /page/14/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. There are also three wave-like lines surrounding the letters inside the circle.

510(k) Premarket Notification Submission

### GE Vivid iq with AcuNav 8F (G version) 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 | PDI | Combined<br>Modes[*] | Harmonic<br>Imaging | Coded<br>Pulse[**] | Other | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | P | P | P | P | P | P | P | P | P | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and<br>Intraluminal | P | P | P | P | P | P | P | P | P | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

[2] Small Organ includes breast, testes, thyroid;

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includ…