Vivid iq

• K Number: K181727
• Device Name: Vivid iq
• Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics,
• Date Cleared: 2018-12-06 ( 160 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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

Device 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.

Predicate Devices

K161706, K170823, K180599, K161588

Reference Devices

K151028, K160078, K163596

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.

Therapeutic

No.
The 'Intended Use' section states the device is primarily for diagnostic imaging and fluid flow analysis, indicating its role in diagnosis rather than treatment.

Diagnostic

Yes
The device is described as an "ultrasound system designed for cardiovascular and shared services applications" with "indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal," all of which are diagnostic applications using diagnostic ultrasound imaging.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "high-performance compact ultrasound system," which is a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Vivid iq is not an IVD (In Vitro Diagnostic) device.

Here's why:

• IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
• Vivid iq Function: The description clearly states that the Vivid iq is an ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve the analysis of specimens taken from the body.
• Intended Use/Indications: The listed indications are all related to imaging various anatomical sites within the body, not analyzing biological samples.

Therefore, the Vivid iq falls under the category of medical imaging devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

Anatomical Site

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.
Abdominal includes GYN and Urological; Small Organ includes breast, testes, thyroid; Cardiac is Adult and Pediatric; Intraoperative includes thoracic(cardiac) and vascular (PV);

Indicated Patient Age Range

Adult, Pediatric, Neonatal (Cephalic), 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)

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.
Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.
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.

K161706, K170823, K180599, K161588

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.

K151028, K160078, K163596

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

Regulation Number and Section

§ 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.

Summary

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December 6, 2018

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

Re: K181727

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

Dear Tracey Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Hse 2. Mild

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number K181727

Device Name Vivid iq

Indications for Use (Describe)

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

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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GE Healthcare 510(k) Premarket Notification Submission

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid iq. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

The following Indication for Use forms are appended:

System: Vivid iq Transducer: 3Sc-RS Transducer: M5Sc-RS Transducer: 6S-RS Transducer: 12S-RS Transducer: 6Tc-RS Transducer: 6VT-D Transducer: P2D Transducer: 9T-RS Transducer: AcuNav 10F (G version) Transducer: AcuNav 8F (G version) Transducer: SOUNDSTAR 3D 10F (G version) Transducer: SOUNDSTAR eco 8F (G version) Transducer: SOUNDSTAR eco 10F (G version) Transducer: 9L-RS Transducer: 12L-RS Transducer: ML6-15-RS Transducer: L8-18i-RS Transducer: 4C-RS Transducer: C1-5-RS Transducer: E8Cs-RS Transducer: 8C-RS

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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The letters are connected and have a flowing, cursive appearance. The circle is surrounded by a decorative, swirling pattern, also in blue, which gives the logo a classic and recognizable look.

GE Healthcare 510(k) Premarket Notification Submission

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

GE Vivid iq Ultrasound System

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[6] RT 3D Mode

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

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

GE Healthcare 510(k) Premarket Notification Submission

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M	PDI	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse[**]	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transcranial	P	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Intracardiac and
Intraluminal
Tissue Biopsy[5]	P			P1		P
Vascular Access (IV, PICC)

GE Vivid iq with 3Sc-RS Transducer

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

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

Notes: [1] Abdominal includes GYN and Urological;

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

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

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

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

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

GE Healthcare 510(k) Premarket Notification Submission

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

GE Vivid iq with M5Sc-RS Transducer

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle.

510(k) Premarket Notification Submission

GE Vivid iq with 6S-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M	PDI	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse[**]	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal [1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ [2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[3]	P1	P1	P1	P1	P1	P1	P1	P1	P1
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transcranial	P	P	P	P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Intracardiac and
Intraluminal
Tissue Biopsy[5]
Vascular Access (IV, PICC)

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

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

GE Healthcare 510(k) Premarket Notification Submission

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

GE Vivid iq with 12S-RS Transducer

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

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

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

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

510(k) Premarket Notification Submission

GE Vivid iq with 6Tc-RS Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

510(k) Premarket Notification Submission

GE Vivid iq with 6VT-D Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

11

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle.

510(k) Premarket Notification Submission

GE Vivid iq with P2D Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

12

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

510(k) Premarket Notification Submission

GE Vivid iq with 9T-RS Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a blue circle. There are also three curved lines that surround the circle.

510(k) Premarket Notification Submission

GE Vivid iq with AcuNav 10F (G version) Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

14

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a blue circle. There are also three wave-like lines surrounding the letters inside the circle.

510(k) Premarket Notification Submission

GE Vivid iq with AcuNav 8F (G version) Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

15

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The color of the letters and the border is blue, while the background within the circle is white.

510(k) Premarket Notification Submission

GE Vivid iq with SOUNDSTAR 3D 10F (G version) Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

16

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular border. The logo is colored in blue, with the letters and the border in the same shade of blue.

510(k) Premarket Notification Submission

GE Vivid iq with SOUNDSTAR eco 8F (G version) Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

17

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The color of the letters and the border is blue, while the background within the circle is white.

510(k) Premarket Notification Submission

GE Vivid iq with SOUNDSTAR eco 10F (G version) Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

18

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

510(k) Premarket Notification Submission

GE Vivid iq with 9L-RS Transducer

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

| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M | PDI | Combined
Modes[*] | Harmonic
Imaging | Coded
Pulse[**] | Other |
|----------------------------------------------------|---|---|---------------|---------------|------------------|---------|-----|----------------------|---------------------|--------------------|-------|
| 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 | P | P | P | | P | | P | P | P | P | |
| 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 | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Intracardiac and
Intraluminal | | | | | | | | | | | |
| Tissue Biopsy[5] | P | | | | P | | P | | P | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

19

Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

510(k) Premarket Notification Submission

GE Vivid iq with 12L-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M	PDI	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse[**]	Other
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	P	P	P		P		P	P	P	P
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
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Intracardiac and
Intraluminal
Tissue Biopsy[5]	P				P		P		P
Vascular Access (IV, PICC)

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

20

Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has a decorative, swirling pattern around the edges. The logo is colored in a shade of blue.

GE Healthcare 510(k) Premarket Notification Submission

---

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M	PDI	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse[**]	Other
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	P	P	P		P		P	P	P	P
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
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Intracardiac and
Intraluminal
Tissue Biopsy[5]	P				P		P		P
Vascular Access (IV, PICC)

GE Vivid ig with ML6-15-RS Transducer

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

N= new indication; P= previously cleared by FDA K161706; P 1= previously cleared by FDA K151028. P = previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

21

Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle, and there are three small, white, cloud-like shapes evenly spaced around the inside of the circle, near the edge.

510(k) Premarket Notification Submission

GE Vivid iq with L8-18i-RS Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

22

GE Vivid iq with 4C-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M	PDI	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse[**]	Other
Ophthalmic
Fetal / Obstetrics	P	P	P		P	P	P	P	P	P
Abdominal [1]	P	P	P		P	P	P	P	P	P
Pediatric	P	P	P		P	P	P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P1	P1	P1		P1		P1	P1	P1	P1
Musculo-skeletal Superficial	P1	P1	P1		P1		P1	P1	P1	P1
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Intracardiac and
Intraluminal
Tissue Biopsy[5]	P				P		P		P
Vascular Access (IV, PICC)

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

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

23

GE Vivid iq with C1-5-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M	PDI	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse[**]	Other
Ophthalmic
Fetal / Obstetrics	P	P	P		P	P	P	P	P	P
Abdominal [1]	P	P	P		P	P	P	P	P	P
Pediatric	P	P	P		P	P	P	P	P	P
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P1	P1	P1		P1		P1	P1	P1	P1
Musculo-skeletal Superficial	P1	P1	P1		P1		P1	P1	P1	P1
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Intracardiac and
Intraluminal
Tissue Biopsy[5]	P				P		P	P	P
Vascular Access (IV, PICC)

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

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

24

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510(k) Premarket Notification Submission

GE Vivid iq with E8Cs-RS Transducer

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

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

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

[1] Abdominal includes GYN and Urological; Notes:

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

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GE Vivid iq with 8C-RS Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M	PDI	Combined
Modes[*]	Harmonic
Imaging	Coded
Pulse[**]	Other
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]	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1
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	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1
Musculo-skeletal Superficial	P1	P1	P1	P1	P1	P1	P1	P1	P1	P1
Other
Exam Type, Means of Access
Transcranial	p3	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 K161706; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K160078. P3= previously cleared by FDA K163596.

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

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

[5] Includes image guidance for freehand needle placement

[6] RT 3D Mode

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

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510(k) Summary K181727

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	June 28, 2018
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:[phone]
Email:[e-mail]
Secondary Contact Person:	Yu Wen
Regulatory Affairs
GE Healthcare
GE Medical Systems China Co., LTD
Device Trade Name:	Vivid iq
Common/Usual Name:	Diagnostic Ultrasound System
Classification Names:	Class II
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90
Product Code:	IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560
90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,
90-ITX
Primary Predicate Device:	Vivid iq (K161706)
Secondary Predicate Device(s):	Vivid E95(K170823)
Venue (K180599)
Vscan Extend (K161588)
Predicates used for changes to transducer applications:
LOGIQ e(K151028), Vivid T8 (K160078), LOGIQ P9 and
LOGIQ P7 (K163596).
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.

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New technology added:	4D Markers function to Vivid iq allow the user to manually place annotations/markers into 3D/4D ultrasound datasets. The purpose is to aid communication between medical personnel, especially to a person not familiar with ultrasound.
	The Tricefy™ Uplink to Vivid iq Apps which includes the interface to Tricefy. Tricefy is a cloud-based solution to support archiving, collaboration and exchange of images, clips and reports. Tricefy and Tricefy Uplink are products of Trice Imaging.
	Qview feature provides a communication pathway with Qpath: Qview is the name of a component provided by the vendor of the popular product Qpath. To access the reporting capability of Qpath product from the ultrasound scanner the user opens the Qview feature. Qpath and Qview are products of Telexy Healthcare.
	QuickApps will allow the user to maintain the current scanning mode and image geometry parameters, such as 2D Depth, 2D Width, Color ROI size and position, as already adjusted by the user, while optimizing other imaging parameters according to a selected scanning situation at any given time.
	View-X functionality is to view a live video stream from another imaging modality at the same time of live ultrasound imaging for informational use when both modalities are used as imaging- support for interventional procedures.
	FlexiViews allow the user quick access to standard user-defined views when scanning with 4D TEE transducers. FlexiViews will store image geometry and a set of scanning parameters.
Intended Use:	The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative,

TransVagmar, Transesophagean
IntraCardiac and Intraluminal.

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| Technology: | The Vivid iq employs the same fundamental scientific technology
as its predicate devices. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination of
Substantial Equivalence: | Comparison to Predicate Devices
The Vivid iq system is substantially equivalent to the predicate
devices with regards to intended use, imaging capabilities,
technological characteristics and safety and effectiveness. The systems are all intended for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications. The Vivid iq and predicate Vivid iq (K161706) have same clinical indications for use. The Vivid iq and predicate Vivid iq (K161706) have identical imaging modes. The Vivid iq and predicate Vivid iq (K161706) systems transducers are the same. Adding clinical applications to the 6S-RS,12S-RS, 4C-RS, C1-5-RS and 8C-RS transducers based on clearances from LOGIQ e (K151028), Vivid T8 (K160078) and LOGIQ P9 and LOGIQ P7 (K163596). Adding new features called FlexiViews, Virtual convex, QuickApps, View-X, Mitral Valve Quantification (MVQ), 4D AVQ. All cleared in predicate Vivid E95(K160078). Adding new feature called Tricefy Uplink, which was cleared in predicate Vscan Extend (K161588). Adding new feature called Qview, which was cleared in predicate Venue (K180599). AFI, Auto EF and Cardiac AutoDoppler features cleared on predicate Vivid iq (K161706) have improvements. Adding Pediatric Z-score based on Z-Scores in the predicate Vivid E95(K170823) with expanded data. The Vivid iq and predicate Vivid iq (K161706) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. The system is 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 predicate Vivid iq (K161706) have been designed in compliance with approved electrical and physical safety standards. |

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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 o Part 1: General Requirements for Safety, 2005/ A2:2012
• 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
• 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), 2016

The proposed Vivid ig Ultrasound System also complies with the FDA ultrasound specific guidance, Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008).

Non-Clinical verification testing has been performed to cover system level requirements and the risk control measures. Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users.

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All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed Vivid iq Ultrasound Systems comply with international and FDArecognized consensus standards and FDA ultrasound guidance document and meet the acceptance criteria and are adequate for their intended use.

Therefore, the proposed Vivid iq Diagnostic Ultrasound Systems are substantially equivalent to the predicate in terms of safety and effectiveness.

The following quality assurance measures are applied to the development of the system:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification) ●
• Performance testing (Verification) ●
• o Safety testing (Verification)

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.

• GE Healthcare considers the Vivid iq to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).