Vivid iq
Device Facts
| Record ID | K161706 |
|---|---|
| Device Name | Vivid iq |
| Applicant | Ge Medical Systems Ultrasound and Primary Care Diagnostics L |
| Product Code | IYN · Radiology |
| Decision Date | Aug 5, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Ultrasound imaging, measurement and analysis of the human body as follows: 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 high-performance compact ultrasound system for cardiovascular and shared services applications. It captures ultrasound signals via various transducers, processing them to produce diagnostic images, measurements, and flow analysis. Used in clinical settings by healthcare professionals; output is displayed on the system monitor for real-time visualization, review, and reporting. The device aids clinical decision-making by providing diagnostic imaging for various anatomical regions and exam types. It features an ergonomic design, advanced connectivity, and productivity tools. It is compatible with the Vivid product family for lab configuration and upgrades.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device relies on bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing, all complying with recognized standards (e.g., IEC 60601-1, IEC 60601-2-37, NEMA UD 2/3).
Technological Characteristics
Compact ultrasound system; uses piezoelectric transducers; supports B, M, PW, CW, Color, Color M, PDI, Combined modes, Harmonic imaging, and Coded pulse. Materials are biocompatible per ISO 10993-1. Connectivity via DICOM. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3.
Indications for Use
Indicated for diagnostic ultrasound imaging, measurement, and analysis of the human body, including fetal, obstetric, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transcranial, transrectal, transvaginal, transesophageal, intraoperative, intracardiac, and intraluminal applications. Used for tissue biopsy and interventional guidance.
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 i and Vivid q (K121062)
- Vivid E95 (K150087)
- Voluson S10 (K160184)
- LOGIQ F8 Expert (K160277)
Reference Devices
- SOUNDSTAR eco 8F (G version) (K140318)
Related Devices
- K243620 — Vivid iq · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 11, 2025
- K181727 — Vivid iq · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 6, 2018
- K221148 — Vivid iq · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Jul 18, 2022
- K102256 — GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND · Ge Medical Systems China Co., Ltd. · Oct 5, 2010
- K102388 — VIVID I DIAGNOSTIC ULTRASOUND SYSTEM · Ge Medical System Israel , Ltd. · Nov 4, 2010
Submission Summary (Full Text)
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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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2016
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K161706 Trade/Device Name: Vivid ig Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 16, 2016 Received: June 20, 2016
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.
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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 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Nam Vivid iq
Indications for Use (Describe)
The Vivid ig is a high-performance compact ultrasound for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatal Cephalic, Adult Cephalic, Adult Cephalic, Cardiac, Penpheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal, Transcranial, Transvectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.
Type of Use (Select one or both, as applicable)
2 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)
FORM FDA 3881 (1/14)
PSC. Publishing Services (301) 443-674
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## 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
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Image /page/5/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 four small circles around the perimeter of the larger circle. The logo is simple and recognizable.
## Diagnostic Ultrasound Indications for Use Form GE Vivid iq Diagnostic Ultrasound System
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|------------------|---------------|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | |
| Abdominal [1] | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Cardiac [3] | N | N | N | N | N | N | N | N | N | N | N |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N | N | N | |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | N |
| Transrectal | N | N | N | N | N | N | N | N | N | N | |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative [4] | N | N | N | N | N | N | N | N | N | N | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | N | N | N | N | N | N | N | N | N | N | |
| Tissue Biopsy[5] | N | N | N | N | N | N | N | N | N | N | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/6/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 four small circles around the perimeter of the larger circle. The logo is simple and recognizable.
#### Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with 3Sc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode |
|-----------------------------------|----|----|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P2 | 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 | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | |
| Cardiac[3] | P | P | P | P | P | P | P3 | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | P4 | P4 | P4 | P4 | P4 | P4 | P4 | P4 | P4 | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | P4 | P4 | | N | | P4 | P4 | P4 | P4 | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/7/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 four small circles around the perimeter of the larger circle. The logo is simple and recognizable.
T
## Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with M5Sc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode |
|-------------------------------|---|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | | |
| Pediatric | N | N | N | N | N | N | N | N | N | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | | |
| Cardiac[3] | N | N | N | N | N | N | N | N | N | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N | N | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | N | N | N | | N | N | N | N | N | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has a swirling design around the letters, giving it a dynamic 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 iq with 6S-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode | |
|-------------------------------|----|----|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|--|
| Anatomy/Region of Interest | | | | | | | | | | | | |
| 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] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | P3 | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc .
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{9}------------------------------------------------
Image /page/9/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 four small circles around the perimeter of the larger circle. The logo is simple and recognizable.
## Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with 12S-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------------|-------------------|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| 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] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N | N | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{10}------------------------------------------------
Image /page/10/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 four small circles around the perimeter of the larger circle. The logo is simple and recognizable.
## Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with 6Tc-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| 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 (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{11}------------------------------------------------
Image /page/11/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 blue circle. The circle has a swirling design around the letters, giving it a dynamic 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 iq with 6VT-D Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|----|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|----|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [3] | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | | p¹ |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | p¹ | | p¹ | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
Image /page/12/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 circular frame. The logo is colored in blue, with the letters and the frame appearing in the same shade of blue.
#### Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with P2D Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-----------------------------------|-------------------|---|----|----|-------|------------|-----|-------------------|---------------------|------------------|---------------|
| | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| 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 (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
Image /page/13/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 four small circles around the perimeter of the larger circle. The logo is simple and recognizable.
## Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with 9T-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined*<br>Modes | Harmonic<br>Imaging | Coded**<br>Pulse | RT 3D<br>Mode | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [3] | P | P | P | P | P | P | P¹ | P | P | P¹ | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P¹ | P | P | P¹ | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
## Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with AcuNav 10F (G version) Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|--|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode | | |
| Anatomy/Region of Interest | | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Intraoperative [4] | P | P | P | P | P | P | N | P | P | | | | |
| Interventional Guidance | | | | | | | | | | | | | |
| Intracardiac and Intraluminal | P | P | P | P | P | P | N | P | P | | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
## Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with AcuNav 8F (G version) Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode |
|-------------------------------|---|---|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | N | N | N | N | N | N | N | N | N | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | P | P | P | P | P | P | N | | P | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{16}------------------------------------------------
Image /page/16/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 blue circle. The circle has a double-line border, with the inner line being slightly thicker than the outer line.
#### Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with SOUNDSTAR 3D 10F (G version) Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative [4] | N | N | N | N | N | N | N | N | N | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Intracardiac and Intraluminal | P | P | P | P | P | P | N | P | P | | | |
| Tissue Biopsy[5] | | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA K121062; P = previously cleared by FDA K150087; P=previously cleared by FDA K160184; P = previously cleared by FDA K160277; P = previously cleared by FDA K160078; P = previously cleared by FDA K140318 by Biosense Webster, Inc.
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;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[**] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{17}------------------------------------------------
Image /page/17/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 blue circle. The circle has a double-line border, with the inner line being slightly thicker than the outer line.
#### Diagnostic Ultrasound Indications for Use Form
## GE Vivid iq with SOUNDSTAR eco 8F (G version) Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|----|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|--|
| Clinical Application | B | M | PW | CW | Color | Color<br>M | PDI | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse** | RT 3D<br>Mode | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal [1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesop…
