Who is the manufacturer of Vivid iq?

Ge Medical Systems Ultrasound And filed the 510(k) submission for Vivid iq (K200708).

What is the FDA product code for Vivid iq?

IYN. It is classified under 21 CFR 892.1550 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Vivid iq?

510(k) clearance (submission type: Traditional).

Does Vivid iq use AI or machine learning?

Yes. Vivid iq (K200708) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Vivid iq?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Vivid iq get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Vivid iq

K200708 · Ge Medical Systems Ultrasound And · IYN · Sep 9, 2020 · Radiology

Device Facts

Record ID	K200708
Device Name	Vivid iq
Applicant	Ge Medical Systems Ultrasound And
Product Code	IYN · Radiology
Decision Date	Sep 9, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1550
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The Vivid iq is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/WD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.

Device Story

Compact diagnostic ultrasound system; cardiovascular and shared services use. Inputs: ultrasound transducer signals (linear, sector, convex, phased array); cardiac signal input for gating. Processing: image reconstruction, measurement, and analysis via integrated software. Outputs: real-time ultrasound images, measurements, and analysis displayed on console monitor. Used in hospitals (OR, Cath/EP labs, echo labs), private offices, and limited outside settings by trained healthcare professionals. Features include AI-based auto-measurement (2D, Doppler spectrum), strain analysis (AFI), and remote viewing (Stream Server). Output assists clinicians in diagnostic decision-making and interventional guidance. Benefits: high-performance imaging in a portable form factor for diverse clinical environments.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety testing, and verification/validation of software features.

Technological Characteristics

Compact ultrasound console with control panel, trackpad, and keyboard. Supports linear, sector, convex, and phased array transducers. Connectivity: USB, wireless. Standards: AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, IEC 62359, ISO 14971, NEMA PS 3.1-3.20 (DICOM). Software includes AI-based measurement and analysis tools.

Indications for Use

Indicated for qualified healthcare professionals to perform ultrasound imaging, measurement, and analysis of the human body and fluid. Applications include fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transcranial, transrectal, transvaginal, transesophageal, interventional guidance, intraoperative, intracardiac, and intraluminal imaging.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Vivid iq (K181727)

Reference Devices

Vivid T8 (K160078)
Vivid E95 (K181685)
Versana Balance (K191792)
Vivid S70N (K200497)

Related Devices

K200497 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 16, 2020
K220619 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 15, 2022
K200851 — Vivid T8, Vivid T9 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 9, 2020
K221147 — Vivid T8, Vivid T9 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 18, 2022
K220882 — Vivid E80, Vivid E90, Vivid E95 · Ge Medical Systems Ultrasound And · Jul 22, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226 Re: K200708 Trade/Device Name: Vivid iq Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 20, 2020 Received: July 21, 2020 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/cfpmp/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. September 9, 2020 If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use #### 510(k) Number K200708 Device Name Vivid iq Indications for Use (Describe) The Vivid is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/WD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities. Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is presented in a light blue color. K200708 GE Healthcare 510(k) Premarket Notification Submission ## 510(k) Summary | Date: | July 20, 2020 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics 9900 Innovation Drive Wauwatosa, WI 53226 | | Primary Contact Person: | Tracey Ortiz Regulatory Affairs Director GE Healthcare T:(262)676-6120 | | Secondary Contact Person: | Wang Yuan Regulatory Affairs GE Healthcare | | Device Trade Name: | Vivid iq | | Common/Usual Name: | Diagnostic Ultrasound System | | Classification Names: | Class II IYN (primary), IYO, ITX (secondary) | | 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 | | Predicate Device: | Vivid iq (K181727) | | Reference Devices: | Vivid T8 (K160078) Vivid E95 (K181685) Versana Balance (K191792) Vivid S70N (K200497) | | Device Description: | The proposed Vivid iq system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, | numeric keyboard. There are options for image storage, USB {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable. ## GE Healthcare 510(k) Premarket Notification Submission wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid iq utilizes a variety of linear, sector, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Intended Use: The Vivid iq is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities. - Technology: The Vivid iq employs the same fundamental scientific technology as its predicate and reference devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular shape. The logo is colored in a light blue hue, and the background is white. GE Healthcare 510(k) Premarket Notification Submission | Determination of | Comparison to Predicate Device | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence: | <ul><li>The Vivid iq system is substantially equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness. There are no additional clinical applications, however the indications for use wording has been modified to align with the new ultrasound guidance, identify users similar to reference device Versana Balance (K191792), and provide information on the environments the system can be used in.</li><li>The Vivid iq and predicate Vivid iq (K181727) have the same transducers</li><li>Adding combine modes B/Color M, B/CWD and B/Color/CWD to 6VT-D transducer already cleared on Vivid E95(K181685).</li><li>AI Auto Measure – 2D: same feature as cleared on Vivid S70N(K200497). It is AI (Artificial Intelligence) based Cardiac Auto 2D feature that enables automated measurements on a PLAX image.</li><li>AI Auto Measure – Spectrum Recognition: same feature as cleared on Vivid S70N(K200497). It is AI based Spectrum Recognition feature that enables automated recognition of common Doppler spectra and automatically starts the Auto Doppler measurement or opens the appropriate manual measurement folder.</li><li>AFI 3.0: same feature as cleared on Vivid S70N(K200497), has the ability to analyze the left ventricle on both GEHC raw data images and DICOM images from 3rd party ultrasound scanners</li><li>Auto EF 3.0: same feature as cleared on Vivid S70N(K200497), has the ability to assess LV function on raw data images acquired with GEHC scanners as well as on DICOM images from other vendors systems.</li><li>AFI RV: same feature as cleared on Vivid S70N(K200497). It is a parametric tool giving quantitative data for right ventricular longitudinal global strain, free wall strain and segmental strain derived from the apical 4-chamber RV focused view.</li><li>AFI LA: same feature as cleared on Vivid S70N(K200497). It provides quantitative data for left atrial (LA) global strain. The tool also supports</li></ul> | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around its perimeter, giving it a vintage or classic appearance. The logo is simple, recognizable, and represents the General Electric brand. # GE Healthcare 510(k) Premarket Notification Submission measurements of LA volumes and emptying fraction (EF). - . HD Color: same feature as cleared on Vivid S70N(K200497). It enhances the perception of 4D color on a 2D monitor by addition of shadowing and specular reflection techniques, providing transparency control. - . 4D Markers: same feature as cleared on predicate Vivid iq (K181727). It is enhanced to allow the user to modify individual markers. - Scan Coach: same feature as cleared on Vivid T8 ● (K160078), is designed to display information which helps user acquire the right scan plane. - Stream Server: same feature as cleared on Vivid E95 ● (K181685), is modified slightly and enables the user to get guidance and/or second opinion by a remote viewer. - . Launchpad: same feature as cleared on Vivid S70N(K200497), allows the display and launch/starting of third-party software apps that have been installed on the system. Only apps that have been qualified and compatibility verified can be installed on the system. - Adding additional lung imaging presets ● - DICOM PDF Read: same feature as cleared on Vivid S70N (200497). The system supports read-only access to DICOM PDF reports created on a DICOM server. ## Summary of Non-Clinical Tests: The proposed Vivid ig 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 ig complies with voluntary standards: - o AAMI/ANSI ES 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance -2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 - IEC 60601-1-2, Medical electrical equipment o Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements {7}------------------------------------------------ Image /page/7/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 white and are set against a blue circular background. The blue circle is surrounded by four stylized white swirls, one on each side of the circle. # GE Healthcare 510(k) Premarket Notification Submission and tests - Edition 4.0, 2014 - IEC 60601-2-37, Medical electrical equipment -O Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment -Edition 2.1, 2015 - ISO 10993-1, Biological Evaluation of Medical O Devices- Part 1: Evaluation and Testing- Third Edition, 2009 - Ф IEC 62359. Ultrasonic - Field characterization -Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields - Edition 2.1, 2017 - ISO 14971, Application of risk management o to medical devices, 2007 - NEMA PS 3.1 3.20, Digital Imaging and O Communications in Medicine (DICOM) Set, 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 & Validation) - · Safety testing (Verification) Transducer material and other patient contact materials are biocompatible. ### Summary of Clinical Tests: Conclusion: The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence > GE Healthcare considers the Vivid iq to be as safe, as effective, and performance is substantially equivalent to the predicate and reference devices.