Vivid T8, Vivid T9

• K Number: K181934
• Device Name: Vivid T8, Vivid T9
• Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
• Date Cleared: 2018-11-06 ( 110 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The Vivid T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.

Device Description

The Vivid T9 / Vivid T8 is a high performance digital ultrasound imaging system with total data management. The system provides image generation in 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications. The fully digital architecture of the Vivid T9 / Vivid T8 unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.

Predicate Devices

K160078

Reference Devices

Vivid E95(K170823), Vivid iq (K161706), Vscan Extend (K180995), LOGIQ e (K151028), LOGIQ P9 and LOGIQ P7 (K163596)

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard digital ultrasound imaging system and does not mention any AI or ML capabilities.

Therapeutic

No
The device is described as an ultrasound imaging system for diagnostic purposes, not for treatment or therapy.

Diagnostic

Yes
Explanation: The device is intended for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications," which are activities performed to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "high performance digital ultrasound imaging system" and mentions "probe types," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Vivid T9 / Vivid T8 is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use clearly states "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications". This describes a device used on the patient for diagnostic imaging, not a device used to test samples taken from the patient.
• Device Description: The description focuses on the imaging capabilities and modes of the ultrasound system. This aligns with an in-vivo imaging device.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Vivid T9 / Vivid T8 is an imaging device used directly on the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vivid T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The Vivid T9 / Vivid T8 is a high performance digital ultrasound imaging system with total data management.
The system provides image generation in 2D (B) Mode, Color Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW and CW Doppler spectral, Tissue Velocity imaging, advanced Strain and Contrast applications.
The fully digital architecture of the Vivid T9 / Vivid T8 unit allows optimal usage of all scanning modes and probe types, throughout the full spectrum of operating frequencies.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.

Notes:
[1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Intraoperative includes abdominal, thoracic and peripheral;
[5] Includes image guidance for freehand needle placement;

Indicated Patient Age Range

Adult and Pediatric

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)

Summary of Non-Clinical Tests:
Vivid T8 / Vivid T9 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 T8 / Vivid T9 complies with voluntary standards:

• . AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safetv, 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 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) ●
• Safety testing (Verification) .
  Transducer material and other patient contact materials are biocompatible.

Summary of Clinical Tests:
The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the Vivid T8 / Vivid T9 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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.

Vivid T8 (K160078)

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.

Vivid E95(K170823), Vivid iq (K161706), Vscan Extend (K180995), LOGIQ e (K151028), LOGIQ P9 and LOGIQ P7 (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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November 6, 2018

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

Re: K181934

Trade/Device Name: Vivid T8, Vivid T9 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 1, 2018 Received: November 2, 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.

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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Hole 2. Nils

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K181934

Device Name Vivid T8, Vivid T9

Indications for Use (Describe)

The Vivid T9 / Vivid T8 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal Cephalic, Musculosketal Superficial/Conventional, Transrectal, Transvaginal, Transesophageal, Intraoperative and Tissue Biopsy.

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 T8 and Vivid T9. 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 T8, Vivid T9 Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: 3Sc-RS Transducer: 6S-RS Transducer: 12S-RS Transducer: 6Tc-RS Transducer: P2D Transducer: L6-12-RS Transducer: 9L-RS Transducer: 12L-RS Transducer: 9T-RS Transducer: L8-18i-RS Transducer: C1-5-RS (Only for Vivid T9) Transducer: E8Cs-RS (Only for Vivid T9)

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510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 Ultrasound System

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	P	P
Abdominal [1]	P	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P	P
Small Organ [2]	P	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	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
Transrectal	P	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P	P
Intraoperative [4]	N	N	N	N	N	N	N	N	N	N	N
Interventional Guidance
Tissue Biopsy / Fluid
Drainage [5]	P				P		P		P

N= new indication; P= previously cleared by FDA K160078; P1= previously cleared by FDA K151028. P= previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

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

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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
Abdominal [1]	P	P	P		P		P	P	P	P
Pediatric	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	N	P1	P1	P1	P1
Musculo-skeletal Superficial	P1	P1	P1		P1	N	P1	P1	P1	P1
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage [5]	P				P		P		P

GE Vivid T8 / Vivid T9 with 4C-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 K160078; P1= previously cleared by FDA K151028. P2= previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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' in a stylized, cursive font, enclosed within a blue circle. The letters are white, creating a contrast against the blue background of the circle.

GE Healthcare 510(k) Premarket Notification Submission

| 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 | P2 | P | P | P | P | |
| Pediatric | P | P | P | | P | P2 | P | P | P | P | |
| Small Organ [2] | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | |
| Neonatal Cephalic | P | P | P | | P | P2 | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P1 | P1 | P1 | | P1 | P2 | P1 | P1 | P1 | P1 | |
| Peripheral Vascular | P | P | P | | P | P2 | P | P | P | P | |
| Musculo-skeletal Conventional | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | |
| Musculo-skeletal Superficial | P1 | P1 | P1 | | P1 | N | P1 | P1 | P1 | P1 | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P3 | P3 | P3 | | P3 | P3 | P3 | P3 | P3 | P3 | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage [5] | | | | | | | | | | | |

GE Vivid T8 / Vivid T9 with 8C-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 K160078; P1= previously cleared by FDA K151028. P2= previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

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

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510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 with E8C-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	P3	P	P	P	P
Abdominal [1]	P	P	P		P	P3	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	P3	P	P	P	P
Transvaginal	P	P	P		P	P3	P	P	P	P
Intraoperative [4]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage[5]	P				P		P1		P

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

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

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510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 with 3Sc-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	P1	P1	P1	P1	P1	P1	P1	P1	P1
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
Tissue Biopsy / Fluid
Drainage[5]	P				P				P

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

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

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510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 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	P2	P	P
Small Organ [2]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
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	P2	P2	P2	P2	P2	P2	P2	P2	P2
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage[5]

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

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

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510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 with 12S-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
Pediatric	P	P	P	P	P	P	P2	P	P
Small Organ [2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
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	P2	P2	P2	P2	P2	P2	P2	P2	P2
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage[5]

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a circular shape, and the entire logo is colored in a shade of blue.

510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 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
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transcranial
Transesophageal	P	P	P	P	P	P		P	P
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage[5]

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a circular shape, and the entire logo is colored in a shade of blue.

510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 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
Tissue Biopsy / Fluid
Drainage[5]

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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' written in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both in a shade of blue, and the background is white.

510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 with L6-12-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
Tissue Biopsy / Fluid
Drainage[5]	P			P	P		P		P

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the well-known multinational corporation.

510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 with 9L-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]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
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]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage[5]	P				P		P		P

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are both in a blue color. The logo is simple and recognizable, representing the well-known multinational corporation.

510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 with 12L 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
Tissue Biopsy / Fluid
Drainage[5]	P				P		P		P

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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 a light blue hue, which is consistent with GE's branding.

GE Healthcare 510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 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]	E	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transcranial
Transesophageal	E	E	E	E	E	E	E	E	E	E
Transrectal
Transvaginal
Intraoperative [4]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage [5]

N= new indication; P= previously cleared by FDA K160078; Pl = previously cleared by FDA K151028. P2= previously cleared by FDA K161706. P3= previously cleared by FDA K163596. E = added under Appendix E per K16706.

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The blue circle has a decorative, wave-like pattern around the letters, giving it a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

GE Vivid T8 / Vivid T9 with L8-18i 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]	E	E	E	E	E	E	E	E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E	E	E	E	E	E	E	E
Musculo-skeletal Conventional	E	E	E	E	E	E	E	E	E	E
Musculo-skeletal Superficial	E	E	E	E	E	E	E	E	E	E
Other
Exam Type, Means of Access
Transcranial
Transesophageal
Transrectal
Transvaginal
Intraoperative [4]	P2	P2	P2	P2	P2	P2	P2	P2	P2	P2
Interventional Guidance
Tissue Biopsy / Fluid
Drainage[5]

N= new indication; P= previously cleared by FDA K160078; Pl= previously cleared by FDA K151028. P2= previously cleared by FDA K161706. P3= previously cleared by FDA K163596. E = added under Appendix E per K16706.

Notes: [1] Abdominal includes GYN and Urological;

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

[3] Cardiac is Adult and Pediatric;

[4] Intraoperative includes abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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 'G' and 'E' intertwined within a circular border. The logo is blue and the background is white.

510(k) Premarket Notification Submission

GE Vivid T9 with C1-5-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 | 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 | P2 | P2 | P2 | | P2 | N | P2 | P2 | P2 | P2 | |
| Musculo-skeletal Superficial | P2 | P2 | P2 | | P2 | N | P2 | P2 | P2 | P2 | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative [4] | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy / Fluid
Drainage[5] | P2 | | | | P2 | | P2 | | P2 | | |

N= new indication; P= previously cleared by FDA K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

[*]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 'g' and 'e' intertwined within a blue circle. The letters are stylized and connected, and the circle has a slightly textured or shaded appearance, giving it a three-dimensional effect.

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	p2	p2	p2		p2	p2	p2	p2	p2	p2
Abdominal [1]	p2	p2	p2		p2	p2	p2	p2	p2	p2
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	p2	p2	p2		p2	p2	p2	p2	p2	p2
Transvaginal	p2	p2	p2		p2	p2	p2	p2	p2	p2
Intraoperative [4]
Interventional Guidance
Tissue Biopsy / Fluid
Drainage [5]	p2				p2		p2		p2

GE Vivid T9 with E8Cs-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 K160078; P = previously cleared by FDA K151028. P = previously cleared by FDA K161706. 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 abdominal, thoracic and peripheral;

[5] Includes image guidance for freehand needle placement;

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

20

Image /page/20/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. The circle is surrounded by a white border with four white water droplets equally spaced around the circle. The logo is simple and recognizable, and it is associated with a well-known and respected company.

K181934

510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	July 17, 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]
[e-mail]
Secondary Contact Person:	Yu Wen
Regulatory Affairs
GE Healthcare
Device Trade Name:	Vivid T8, Vivid T9
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 T8 (K160078)
Secondary Predicate Device(s):	Vivid E95(K170823)
Vivid iq (K161706)
Vscan Extend (K180995)
Additional predicates used for changes to transducer applications:
LOGIQ e (K151028), LOGIQ P9 and LOGIQ P7 (K163596).
Device Description:	The Vivid T9 / Vivid T8 is a high performance digital ultrasound
imaging system with total data management.
The system provides image generation in 2D (B) Mode, Color
Doppler, Power Doppler (Angio), M-Mode, Color M-Mode, PW
and CW Doppler spectral, Tissue Velocity imaging, advanced
Strain and Contrast applications.
The fully digital architecture of the Vivid T9 / Vivid T8 unit
allows optimal usage of all scanning modes and probe types,
throughout the full spectrum of operating frequencies.
Intended Use:	The Vivid T9 / Vivid T8 is intended for ultrasound imaging,
measurement and analysis of the human body for multiple clinical
applications including: Fetal/OB, Abdominal, Pediatric, Small
Organ, Cardiac, Peripheral Vascular, Adult Cephalic, Neonatal
Cephalic, Musculoskeletal Superficial/Conventional,
Transcranial, Transrectal, Transvaginal, Transesophageal,
Intraoperative and Tissue Biopsy.
Technology:	The Vivid T8 / Vivid T9 employs the same fundamental scientific
technology as its predicate devices.
Determination of
Substantial Equivalence:	Comparison to Predicate Devices
The Vivid T8 / Vivid T9 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 T8, Vivid T9 and predicate Vivid T8
(K160078) have similar clinical indications for use,
however the proposed Vivid T8 / Vivid T9 has the
Intraoperative indication which has been cleared on
predicate Vivid iq (K161706). The Vivid T8, Vivid T9 and predicate Vivid T8 have
identical imaging modes. The Vivid T8, Vivid T9 and predicate Vivid T8
(K160078) transducers are similar, except for adding C1-
5-RS and E8Cs-RS on Vivid T9 which were cleared with
predicate Vivid iq (K161706). The 9T-RS and the L8-
18i-RS transducers were previously added though
appendix E of the ultrasound guidance. However
intraoperative is now being added to the L8-18i-RS
transducer per predicate Vivid iq (K161706). The Vivid T8 / Vivid T9 is adding clinical applications to
the 4C-RS, 8C-RS, 3Sc-RS,6S-RS, 12S-RS, 9T-RS, L8-
18i-RS, C1-5-RS and E8Cs-RS transducers that were
cleared on prior systems. The Vivid T8 / Vivid T9 is adding new features called
Virtual convex, QuickApps, Cardiac AutoDoppler,
Virtual Apex, Strain and Strain Rate, which were all
cleared in predicate Vivid E95 (K170823).

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 three water droplets surrounding the letters. The logo is simple and recognizable, and it is associated with a well-known company.

510(k) Premarket Notification Submission

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 three water droplet shapes around the outside of the circle. The logo is simple and recognizable.

510(k) Premarket Notification Submission

• The Vivid T8 / Vivid T9 is adding a new feature called ● Tricefy Uplink, which was cleared with predicate Vscan Extend (K180995).
• AFI and Auto EF which were cleared on predicate Vivid ● T8 (K160078) have improvements made to them.
• Adding Pediatric Z-score based on Z-Scores cleared in the predicate Vivid E95(K170823) includes expanded data.
• The Vivid T8. Vivid T9 and predicate Vivid T8 ● (K160078) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
• . 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 T8, Vivid T9 and predicate Vivid T8 (K160078) ● have been designed in compliance with approved electrical and physical safety standards.

Summary of Non-Clinical Tests:

Vivid T8 / Vivid T9 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 T8 / Vivid T9 complies with voluntary standards:

• . AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safetv, 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

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 script in the center. There are three water droplet shapes around the outside of the circle. The logo is simple and recognizable.

510(k) Premarket Notification Submission

• 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 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) ●
• Safety testing (Verification) .

Transducer material and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence.

• Conclusion: GE Healthcare considers the Vivid T8 / Vivid T9 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).