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
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K160078
• Predicate For: K200851

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.

AI/ML Overview

The document is a 510(k) Premarket Notification Submission for the GE Vivid T8 and Vivid T9 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through new clinical studies.

Based on the provided text, there are no specific acceptance criteria or a study detailed that directly proves the device meets such criteria in terms of diagnostic accuracy or effectiveness. Instead, the submission focuses on comparing the new device to predicate devices to establish substantial equivalence.

Here's a breakdown of the information that can be extracted, particularly in relation to the questions asked, even if direct answers for "acceptance criteria" and "study proving it" are not present:

1. Table of Acceptance Criteria and Reported Device Performance:
   Not applicable in the direct sense of a new study with explicit performance metrics against acceptance criteria. The document claims "performance is substantially equivalent to the predicate device(s)" based on similar technology, intended use, imaging capabilities, and safety/effectiveness. The performance comparison is implicitly tied to the cleared performance of the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states: "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." Therefore, no test set sample size, data provenance, or study type (retrospective/prospective) is provided for a new clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Since no new clinical studies were conducted to establish performance against ground truth, this information is not available in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no new clinical performance study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This is a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable, as no new clinical performance study was required. The "ground truth" for substantial equivalence is based on the previously established safety and effectiveness of the predicate devices.

8. The sample size for the training set:
   Not applicable for a clinical training set, as no new clinical studies were conducted. The device's "training" refers to its design and evaluation based on engineering principles and comparison to existing, cleared technologies.

9. How the ground truth for the training set was established:
   Not applicable.

Summary of what the document focuses on instead:

The submission relies on demonstrating Substantial Equivalence to legally marketed predicate devices, primarily the Vivid T8 (K160078), Vivid E95 (K170823), Vivid iq (K161706), and Vscan Extend (K180995), along with other LOGIQ systems for specific transducer applications.

The key points for establishing substantial equivalence are:

• Intended Use: The Vivid T9 / Vivid T8 shares the same intended use as predicate devices: ultrasound imaging, measurement, and analysis of the human body for multiple clinical applications (Fetal/OB, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular, Adult/Neonatal Cephalic, Musculoskeletal Superficial/Conventional, Transcranial, Transrectal, Transvaginal, Transesophageal, Intraoperative, and Tissue Biopsy).
• Technological Characteristics: The device employs the same fundamental scientific technology as its predicate devices.
• Imaging Modes: Identical imaging modes to the predicate Vivid T8 (K160078).
• Transducers: Similar transducers, with new additions (C1-5-RS and E8Cs-RS for Vivid T9) and expanded applications for existing transducers (e.g., Intraoperative for L8-18i-RS, and various clinical applications for 4C-RS, 8C-RS, 3Sc-RS, 6S-RS, 12S-RS, 9T-RS, L8-18i-RS, C1-5-RS, E8Cs-RS) that were cleared on other predicate systems.
• New Features: New features like Virtual convex, QuickApps, Cardiac AutoDoppler, Virtual Apex, Strain and Strain Rate, and Pediatric Z-score (expanded data) were cleared in predicate Vivid E95 (K170823). Tricefy Uplink was cleared with predicate Vscan Extend (K180995). Improvements were made to AFI and Auto EF, which were cleared on predicate Vivid T8 (K160078).
• Safety and Performance: The systems are manufactured with safe materials, have acoustic power levels below FDA limits, and comply with approved electrical and physical safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM). Quality assurance measures (Risk Analysis, Requirements/Design Reviews, various levels of testing) are applied.

Conclusion: The document explicitly states that the device "did not require clinical studies to support substantial equivalence." This means that the acceptance criteria are largely met by demonstrating that the device is as safe and effective as existing, legally marketed ultrasound systems, based on an engineering and feature-by-feature comparison rather than a new clinical trial with specific performance metrics.

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

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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

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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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Image /page/4/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 Ultrasound System

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage [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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Image /page/5/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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage [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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage [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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Image /page/7/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 shape. The letters and the circle are in a blue color, set against a white background.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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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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 shape, and the entire logo is colored in a shade of blue.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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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Image /page/9/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 6S-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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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Image /page/10/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 shape. The letters and the circle are in a blue color, set against a white background.

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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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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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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage [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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage[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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color M	PDI	CombinedModes[*]	HarmonicImaging	CodedPulse[**]	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 / FluidDrainage [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 Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:[phone]
Secondary Contact Person:	Yu WenRegulatory AffairsGE 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 ultrasoundimaging system with total data management.The system provides image generation in 2D (B) Mode, ColorDoppler, Power Doppler (Angio), M-Mode, Color M-Mode, PWand CW Doppler spectral, Tissue Velocity imaging, advancedStrain and Contrast applications.The fully digital architecture of the Vivid T9 / Vivid T8 unitallows 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 clinicalapplications including: Fetal/OB, Abdominal, Pediatric, SmallOrgan, Cardiac, Peripheral Vascular, Adult Cephalic, NeonatalCephalic, Musculoskeletal Superficial/Conventional,Transcranial, Transrectal, Transvaginal, Transesophageal,Intraoperative and Tissue Biopsy.
Technology:	The Vivid T8 / Vivid T9 employs the same fundamental scientifictechnology as its predicate devices.
Determination ofSubstantial Equivalence:	Comparison to Predicate DevicesThe Vivid T8 / Vivid T9 system is substantially equivalent to thepredicate devices with regards to intended use, imagingcapabilities, technological characteristics and safety andeffectiveness. The systems are all intended for ultrasound imaging,measurement and analysis of the human body and fluidfor 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 theIntraoperative indication which has been cleared onpredicate Vivid iq (K161706). The Vivid T8, Vivid T9 and predicate Vivid T8 haveidentical 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 withpredicate Vivid iq (K161706). The 9T-RS and the L8-18i-RS transducers were previously added thoughappendix E of the ultrasound guidance. Howeverintraoperative is now being added to the L8-18i-RStransducer per predicate Vivid iq (K161706). The Vivid T8 / Vivid T9 is adding clinical applications tothe 4C-RS, 8C-RS, 3Sc-RS,6S-RS, 12S-RS, 9T-RS, L8-18i-RS, C1-5-RS and E8Cs-RS transducers that werecleared on prior systems. The Vivid T8 / Vivid T9 is adding new features calledVirtual convex, QuickApps, Cardiac AutoDoppler,Virtual Apex, Strain and Strain Rate, which were allcleared 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).

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.