No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention any features or technologies typically associated with AI/ML in the device description or performance studies.
No
The device is described as an ultrasound system for imaging, with indications for various diagnostic applications, and no mention of therapeutic use.
Yes
The device is described as an ultrasound for cardiovascular and shared services applications with indications for various anatomical sites and medical uses (e.g., Fetal, OB, Abdominal, Cardiac), which are typical applications for diagnostic devices used to visualize internal body structures and assess conditions.
No
The device description explicitly states it is a "compact ultrasound system," which is a hardware device. The indications for use also describe applications for an ultrasound system.
Based on the provided information, the Vivid iq is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Vivid iq clearly states it is an ultrasound system used for imaging various anatomical sites within the body.
- The intended use and device description focus on imaging and visualization of internal structures. There is no mention of analyzing biological samples.
- The listed indications for use are all related to imaging procedures.
Therefore, the Vivid iq is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. It offers an innovative ergonomic design, superb image quality, advanced connectivity, productivity tools and advanced technology. Compatibility with the Vivid product family offers flexibility in lab configuration and upgrade opportunities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging
Anatomical Site
Fetal, OB, Abdominal, Pediatric Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Thoracic (cardiac), Vascular (PV), Breast, Testes, Thyroid, IV, PICC
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K121062, K150087, K160184, K160277
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K160078, K140318 by Biosense Webster, Inc.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
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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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael 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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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 PRAStaff@fda.hhs.gov
"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."
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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 | |||||
| M | PDI | Combined | |||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse** | RT 3D | ||||||||||
| 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
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
Mode |
|-----------------------------------|----|----|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| 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) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| 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
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
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
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
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)
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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 | ||||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse** | RT 3D | ||||||||||
| Mode | |||||||||||
| Anatomy/Region of Interest | |||||||||||
| 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) | |||||||||||
| 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] | |||||||||||
| 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 | ||||||
| M | PDI | Combined | ||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse** | RT 3D | |||||||||||
| 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 | ||||||
| M | PDI | Combined | ||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse** | RT 3D | |||||||||||
| 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 | ||||||
| M | PDI | Combined | |||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse** | RT 3D | ||||||||||
| Mode | |||||||||||
| Anatomy/Region of Interest | |||||||||||
| 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 | ||||||
| M | PDI | Combined* | ||||||||||
| Modes | Harmonic | |||||||||||
| Imaging | Coded** | |||||||||||
| Pulse | RT 3D | |||||||||||
| 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 | |||||||
| M | PDI | Combined | |||||||||||
| Modes* | Harmonic | ||||||||||||
| Imaging | Coded | ||||||||||||
| Pulse** | RT 3D | ||||||||||||
| 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
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
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 | ||||||
| M | PDI | Combined | ||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse** | RT 3D | |||||||||||
| 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 | ||||||
| M | PDI | Combined | ||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse** | RT 3D | |||||||||||
| 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 | p5 | p5 | p5 | p5 | p5 | p5 | p5 | p5 | p5 | |||
| 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)
18
Image /page/18/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 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 10F (G version) Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | | B | M | PW | CW | Color | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
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)
19
Image /page/19/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 9L-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | PW | CW | Color | Color M | PDI | Combined Modes | Harmonic Imaging | Coded Pulse | RT 3D Mode |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| 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 | P4 | P4 | P4 | P4 | P4 | P4 | P4 | P4 | P4 | P4 | |
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| 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 (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative[4] | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy[5] | P4 | P4 | P4 | P4 | P4 | P4 | 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/20/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 12L-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 | |||||
| M | PDI | Combined | |||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse** | RT 3D | ||||||||||
| Mode | |||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal [1] | P | P | P | P | P | P | P | P | |||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ [2] | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | P4 | P4 | P4 | P4 | P4 | P4 | P4 | P4 | |||
| Adult Cephalic | |||||||||||
| Cardiac [3] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | |||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative [4] | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| Tissue Biopsy[5] | P4 | P4 | P4 | P4 | 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)
21
Image /page/21/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 ML6-15-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | PW | CW | Color | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
Mode |
|-------------------------------|----|----|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | p2 | |
| Pediatric | p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | p2 | |
| Small Organ[2] | p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | p2 | |
| Neonatal Cephalic | N | N | N | | N | | N | N | N | N | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | p2 | |
| Musculo-skeletal Conventional | p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | p2 | |
| Musculo-skeletal Superficial | p2 | p2 | p2 | | p2 | | p2 | p2 | p2 | p2 | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| 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)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
22
Image /page/22/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 L8-18i-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 M | PDI | Combined Modes | Harmonic Imaging | Coded Pulse** | RT 3D Mode |
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal [1] | |||||||||||
| Pediatric | |||||||||||
| Small Organ [2] | p3 | p3 | p3 | p3 | N | p3 | p3 | p3 | N | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | |||||||||||
| Peripheral Vascular | p3 | p3 | p3 | p3 | N | p3 | p3 | p3 | N | ||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | ||
| Musculo-skeletal Superficial | p3 | p3 | p3 | p3 | N | p3 | p3 | p3 | N | ||
| 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 | |||||||||||
| 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)
23
Image /page/23/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 4C-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 | ||||||
| M | PDI | Combined | ||||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse** | RT 3D | |||||||||||
| 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 | P4 | P4 | P4 | P4 | N | P4 | P4 | P4 | P4 | |||
| 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] | ||||||||||||
| Interventional Guidance | ||||||||||||
| Intracardiac and Intraluminal | ||||||||||||
| Tissue Biopsy[5] | P4 | P4 | N | 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)
24
Image /page/24/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 C1-5-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 | |||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse** | RT 3D | ||||||||||
| Mode | |||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | p2 | p2 | p2 | p2 | p2 | p2 | p2 | p2 | p2 | ||
| Abdominal[1] | p2 | p2 | p2 | p2 | p2 | p2 | p2 | p2 | p2 | ||
| Pediatric | p2 | p2 | p2 | p2 | p2 | p2 | p2 | p2 | p2 | ||
| 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] | |||||||||||
| Interventional Guidance | |||||||||||
| Intracardiac and Intraluminal | |||||||||||
| 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)
25
Image /page/25/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 E8Cs-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | PW | CW | Color | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
Mode |
|-----------------------------------|----|----|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P3 | P3 | P3 | | P3 | N | P3 | P3 | P3 | N | |
| Abdominal[1] | P3 | P3 | P3 | | P3 | N | P3 | P3 | P3 | N | |
| 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 | P3 | P3 | P3 | | P3 | N | P3 | P3 | P3 | N | |
| Transvaginal | P3 | P3 | P3 | | P3 | N | P3 | P3 | P3 | N | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | P3 | P3 | P3 | | P3 | N | P3 | P3 | P3 | 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)
26
Image /page/26/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 8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | PW | CW | Color | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse** | RT 3D
Mode |
|-----------------------------------|---|---|----|----|-------|------------|-----|--------------------|---------------------|------------------|---------------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| 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] | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | |
| 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)
27
Image /page/27/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 swirls around the perimeter, giving it a classic and recognizable appearance.
510(k) Summary
| Date: | June 16, 2016 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)676-6120 | |
| F:(414)918-8275 | |
| Secondary Contact Person: | Nick Xu |
| Regulatory Affairs | |
| GE Medical Systems (China) Co, Ltd. | |
| T: +86 510 8527 8639 | |
| F: +86 510 8522 7347 | |
| Device: | |
| Trade Name: | Vivid iq |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90 |
| IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, | |
| 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, | |
| 90-ITX | |
| Primary Predicate Device: | Vivid i and Vivid q (K121062) |
| Secondary Predicate | |
| Device(s): | Vivid E95 (K150087) |
| Voluson S10 (K160184) | |
| LOGIQ F8 Expert (K160277) | |
| Device Description: | The Vivid iq is a high-performance compact ultrasound system |
| designed for cardiovascular and shared services applications. It | |
| offers an innovative ergonomic design, superb image quality, | |
| advanced connectivity, productivity tools and advanced | |
| technology. Compatibility with the Vivid product family offers | |
| flexibility in lab configuration and upgrade opportunities. | |
| 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 |
28
Image /page/28/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are three curved lines emanating from the circle at the top and bottom, giving the impression of motion or energy.
GE Healthcare
510(k) Premarket Notification Submission
Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.
Technology: The Vivid iq employs the same fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicate Devices
Substantial Equivalence: The Vivid iq system is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The Vivid iq and its predicate Vivid i and Vivid q (K121062) have the same clinical indications for use except for tissue biopsy which was cleared in LOGIQ F8 Expert (K160277).
- The Vivid iq and its predicate Vivid i and Vivid q ● (K121062) have the same imaging modes except Real Time 3D mode which has been cleared in Vivid E95 (K150087).
- The Vivid iq and its predicate Vivid i and Vivid q ● (K121062) transducers are identical except for the M5Sc-RS, E8Cs-RS, L8-18i-RS, ML6-15-RS, C1-5-RS, 6VT-D, and SOUNDSTAR eco 8F (G version) probes.
- The 6VT-D and M5Sc-RS (equivalent to M5Sc-D with only a change in RS connector) probes are being added and were cleared on Vivid E95 (K150087).
- The E8Cs-RS and L8-18i-RS probes are being added and ● were cleared in LOGIQ F8 Expert (K160277).
- The ML6-15-RS and C1-5-RS are being added and were cleared in Voluson S10 (K160184).
- The SOUNDSTAR eco 8F (G version) is being added and was cleared in K140318 by Biosense Webster, Inc.
- . The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- The systems have acoustic power levels which are below the applicable FDA limits.
- The Vivid iq and its predicate Vivid i and Vivid q ● (K121062) have similar capability in terms of performing
29
Image /page/29/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. There are decorative swirls or flourishes around the outer edge of the circle. The logo is in a light blue color.
measurements, capturing digital images, reviewing and reporting studies.
- The Vivid iq and its predicate Vivid i and Vivid q ● (K121062) have been designed in compliance with approved electrical and physical safety standards.
- The embedded operating system used is Windows 7 as it . is in LOGIO F8 Expert (K160277).
Summary of Non-Clinical Tests:
Vivid iq has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Vivid iq complies with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety, 2005
- IEC60601-1-2, Medical Electrical Equipment Part 1-● 2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
- IEC60601-2-37, Medical Electrical Equipment Part 2-● 37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
- ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition, 2009
- NEMA UD 2, Acoustic Output Measurement Standard for ● Diagnostic Ultrasound Equipment, 2004
- ISO14971, Application of risk management to medical devices. 2007
- NEMA. Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2011
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews ●
- Design Reviews .
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- Testing on unit level (Module verification) ●
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification) ●
- Simulated use testing (Validation) o
Transducer material and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the Vivid iq to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).