Vivid Explorer/Vivid Advanced/Vivid Focus

K261313 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Sep 2, 2026 · Radiology

Device Facts

• Record ID: K261313
• Device Name: Vivid Explorer/Vivid Advanced/Vivid Focus
• Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
• Product Code: IYN · Radiology
• Decision Date: Sep 2, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, PCCP, Pediatric

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Cardiac Doppler spectrum velocity traces	Three constituent AI models: Doppler Spectrum Cycle Detection, Tissue Doppler, and Doppler Trace networks.	Feasibility score > 95% and accuracy threshold calculated as mean absolute difference in percentage.	—	Training dataset: 9607 recordings from 20 unique clinical sites.	>1 (cardiologists) + >1 (clinical experts)	AI Doppler Spectrum Cycle Detection: 3197 recordings; Tissue Doppler: 1570 recordings; Doppler Trace: 1628 recordings.	4 (cardiologists) + 5 (clinical experts)

Indications for Use

Vivid Explorer, Vivid Advanced and Vivid Focus are general-purpose ultrasound systems, specialized for use in cardiac imaging. They are intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid Explorer is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include 3D/ 4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. Vivid Advanced is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. Vivid Focus is intended for use in a hospital environment including echo lab, other hospital settings, operating room and Cath lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Device Story

Mobile diagnostic ultrasound systems (Vivid Explorer, Vivid Advanced, Vivid Focus) for cardiac, vascular, and general radiology imaging; operated by physicians in hospitals (echo labs, OR, Cath/EP labs) or private offices. Systems utilize electronic array transducers (linear, curved, sector/phased, matrix, dual, CW, 3D/4D) to acquire ultrasound signals. cSound architecture performs software-based beamforming and adaptive image formation to reconstruct images. Features include AI-driven cardiac Doppler analysis, automated tissue optimization, and various measurement/quantification tools (e.g., LAA sizing, Myocardial Work, 4D Auto MVQ/TVQ). Output displayed on integrated LCD monitors; data exportable to PACS/DICOM. Benefits include improved diagnostic confidence, streamlined clinical workflows, and bedside scanning capability via battery mode. PCCP included for AI Cardiac Auto Doppler software updates.

Clinical Evidence

Bench testing only. No clinical studies required. Performance verified via acoustic output, biocompatibility, electrical/mechanical safety, and electromagnetic compatibility testing. AI Cardiac Auto Doppler verified using independent datasets (thousands of recordings) across diverse demographics and ultrasound consoles, demonstrating accuracy against cardiologist-annotated ground truth.

Technological Characteristics

Mobile ultrasound console with height-adjustable control panel and LCD touch interface. cSound software-based beamforming architecture. Supports linear, curved, sector/phased, matrix, and dual array transducers. Connectivity via LAN/wireless. Biocompatible patient-contact materials. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Indications for Use

Indicated for ultrasound imaging, measurement, display, and analysis of human body and fluid in neonates, infants, children, adolescents, and adults. Applications include cardiac, fetal/obstetrics, abdominal, pediatric, small organ, cephalic, peripheral vascular, musculoskeletal, urology, transesophageal, transvaginal, transrectal, transcranial, intra-cardiac, intra-luminal, and interventional guidance.

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 S70N/S60N (K223832)

Reference Devices

• Vivid Pioneer (K251169)
• Vivid T9/T8 (K243628)
• Versana Premier (K242005)
• Vivid iq (K243620)
• Vivid E95 (K170823)
• Vivid E95 (K181685)
• Vivid E95 (K200743)
• AcuNav Crystal Ultrasound Catheter (K233270)
• SOUNDSTAR CRYSTAL Ultrasound Catheter (K240050)
• CARTO 3 Navigation and mapping device (K223733)
• Nuvision NAV and Non-NAV Intra Cardiac Catheter (K241540)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG
ADMINISTRATION

September 2, 2026

GE Medical Systems Ultrasound and Primary Care Diagnostics
Yuan Wang
Senior Lead Specialist, Regulatory Affairs
3200 N Grandview Blvd.
Waukesha, Wisconsin 53188

Re: K261313

Trade/Device Name: Vivid Explorer/Vivid Advanced/Vivid Focus
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX, QIH
Dated: July 31, 2026
Received: July 31, 2026

Dear Yuan Wang:

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 (the 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 available 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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261313 - Yuan Wang

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premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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K261313 - Yuan Wang

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

YANNA S. KANG -S

Yanna Kang, Ph.D.

Assistant Director

Mammography and Ultrasound Team

DHT8C: Division of Radiological

Imaging and Radiation Therapy Devices

OHT8: Office of Radiological Health

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261313 | ? |
| Please provide the device trade name(s). | | ? |
| Vivid Explorer/Vivid Advanced/Vivid Focus | | |
| Please provide your Indications for Use below. | | ? |
| Vivid Explorer, Vivid Advanced and Vivid Focus are general-purpose ultrasound systems, specialized for use in cardiac imaging. They are intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. | | |
| Vivid Explorer is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include 3D/ 4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. | | |
| Vivid Advanced is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. | | |
| Vivid Focus is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room and Cath lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, | | |

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Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| --- | --- | --- |
| Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |

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510(k) Premarket Notification Submission

510(k) Summary: K261313

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

Date: September 2, 2026

Submitter: GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
3200 N Grandview Blvd
Waukesha, WI 53188, USA

Manufacturer: GE Vingmed Ultrasound AS
Strandpromenaden 45
3191 Horten, Norway

Primary Contact Person: Wang Yuan Cathy
Senior Lead Specialist, Regulatory Affairs
GE HealthCare
Tel: [phone]
Email: [e-mail]

Alternate Contact Person: Michelle Huettner
Director, Regulatory Affairs
GE HealthCare
Tel: [phone]
Email: [e-mail]

Device Trade Name: Vivid Explorer/Vivid Advanced/Vivid Focus

Common/Usual Name: Diagnostic Ultrasound System

Classification Names: Class II

Product Code: IYN (primary), IYO, ITX, QIH
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
Medical image management and processing system, 21 CFR 892.2050,
90-QIH

Primary Predicate Device: K223832 Vivid S70N/S60N

Reference Device(s):
K251169 Vivid Pioneer
K243628 Vivid T9/T8
K242005 Versana Premier
K243620 Vivid iq

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K170823 Vivid E95

K181685 Vivid E95

K200743 Vivid E95

Classification Names: Class II

Product Code: IYN (primary)

Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN;

Subsequent Product Codes: IYO, ITX

Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;

Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

Device Description:

Vivid Explorer is a diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. The Vivid Explorer consists of a mobile console with a height-adjustable control panel, a tiltable LCD touch panel, a display monitor with an articulating arm, and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The system can also be used with compatible 2D and 4D ICE transducers.

Vivid Advanced is a diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. Vivid Advanced consists of a mobile console with a height-adjustable control panel, a tiltable LCD touch panel, and a display monitor with an articulating arm. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducers with multi-plane imaging. The system can also be used with compatible 2D ICE transducers.

Vivid Focus is a diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. The Vivid Focus consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers.

Vivid Explorer is equipped with either a 23.8-inch HDU display (standard) or a 23.8-inch LCD display (optional). Vivid Advanced includes a 23.8-inch LCD display, and Vivid Focus includes either a

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21.5-inch LCD display (standard) or a 23.8-inch LCD display (optional).

All systems, Vivid Explorer, Vivid Advanced and Vivid Focus, incorporate a common user interface, consisting of pre-defined hard-key controls and a 15.6-inch fixed or tiltable multi-touch LCD panel with mode- and operation-dependent soft keys.

The operator panel of all systems Vivid Explorer, Vivid Advanced and Vivid Focus also includes two loudspeakers for audio, an optional storage tray for convenient placement of paper or accessories, 6 probe holders, and a range of fixed hooks and optional elastic hooks for neat cable management for the connected transducers and other cables. An optional gel warmer can be securely installed in the system probe holder and connected to the system USB port for power supply.

The lower console is mounted on 4-wheel individual brake, for ergonomic transport and safe parking. The lower console also includes all electronics for transmitting and receiving ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection., An optional storage basket, an optional lower base tray, and optional dual set of storage bins can be mounted on the lower console for optimal storage of accessories needed for bedside scanning.

Vivid Explorer, Vivid Advanced and Vivid Focus include capability to output data to other devices like printing devices.

**Intended Use:** Vivid Explorer, Vivid Advanced and Vivid Focus are general-purpose ultrasound systems, specialized for use in cardiac imaging. They are intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid.

Vivid Explorer is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional

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510(k) Premarket Notification Submission

Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include 3D/ 4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Vivid Advanced is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Vivid Focus is intended for use in a hospital environment including echo lab, other hospital settings, operating room and Cath lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (includes renal, GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (includes prostate), Transesophageal, Transvaginal, Transrectal, Transcranial, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Technology: The Vivid Explorer/Vivid Advanced/Vivid Focus employs the same fundamental scientific technology as its predicate device.

Determination of Substantial Equivalence: Comparison to Predicates. The proposed devices Vivid Explorer/Vivid Advanced/Vivid Focus are substantially equivalent to the predicate device Vivid S70N (K223832) with regards to imaging capabilities, technological characteristics and safety and effectiveness.

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510(k) Premarket Notification Submission

The following is an overview of the differences between the proposed devices Vivid Explorer/Vivid Advanced/Vivid Focus and the predicate device Vivid S70N (K223832).

Indications for Use

The proposed device Vivid Explorer has identical Indications for Use to the predicate device Vivid S70N (K223832).

The proposed device Vivid Advanced has similar Indications for Use to the predicate device Vivid S70N (K223832), except that Vivid Advanced does not support 3D/4D imaging modes.

The proposed device Vivid Focus has similar Indications for Use to the predicate device Vivid S70N (K223832), except that Vivid Focus is not intended for use in EP lab, does not support intracardiac or intraluminal applications, and does not support 3D/4D imaging modes.

The proposed device Vivid Focus has identical Indications for Use to the cleared reference device Vivid T9 (K243628).

Transducers

The proposed devices Vivid Explorer/Vivid Advanced/Vivid Focus and predicate device Vivid S70N (K223832) transducers are similar, except for:

- Addition of 9VT-D transducer on Vivid Explorer and Vivid Advanced with identical indication for use and identical modes of operation as the 9VT-D on cleared reference device Vivid Pioneer (K251169)
- Addition of 6Sc-D transducer on Vivid Explorer and Vivid Advanced with identical Indications for Use and identical Modes of Operation as the 6Sc-D on cleared reference device Vivid Pioneer (K251169)
- Addition of IC9-RS transducer on Vivid Focus with identical indication for use and similar modes of operation as on cleared reference device Versana Premier (K242005)
- Addition of new 4Sc-RS transducer on Vivid Focus with same identical indication for use of 3Sc-RS on predicate Vivid S70N (K223832)
- Addition of transducers 6S-RS, 12S-RS, 9L-RS, 12L-RS, L4-20t-RS, 4C-RS, 8C-RS, C1-5-RS, P2D-RS, L8-18i-RS on Vivid Focus have similar indication for use and modes of operations on reference device Vivid T9 (K243628)

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# Software Features/Functionality

- **AI Cardiac Auto Doppler**: Enhanced the ability to perform cardiac cycle detection and analysis independently of ECG signals, broadening the applicability and usability in clinical settings of the AI Cardiac Auto Doppler cleared on the reference device Vivid Pioneer (K251169). The workflow supported Doppler spectrum types, and clinical parameters of the modified AI Cardiac Auto Doppler (with and without ECG) are the same as cleared on the reference device Vivid Pioneer (K251169).

- AI Cardiac Auto Doppler is intended to be used within the process of doing quantitative evaluation of Doppler acquisitions which provide velocity traces and peak velocity landmarks on Cardiac Doppler Spectrums.

- AI Cardiac Auto Doppler is indicated for the quantitative evaluation of Doppler acquisitions obtained from Adult and Pediatric patients using transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) probes.

- A **Predetermined Change Control Plan (PCCP)** is included and applies exclusively to the AI Cardiac Auto Doppler software feature. Modifications implemented under the PCCP are limited to controlled updates that remain within the cleared intended use of AI Cardiac Auto Doppler. These modifications do not introduce new measurement types, new diagnostic claims, expanded clinical indications, or changes to clinical interpretation of AI Cardiac Auto Doppler results. The type, format, and clinical meaning of AI Cardiac Auto Doppler outputs remain unchanged.

- Planned modifications under the PCCP may include, as applicable:

- Modification to the core AI algorithms, including the three constituent AI models:

- Doppler Spectrum Cycle Detection Model
- Tissue Doppler Network
- Doppler Trace Network

- Optimization of software implementation, including supporting post-processing components, provided that algorithm outputs, measurement definitions, clinical results, and user interactions remain unchanged

- Support for additional cardiac ultrasound TTE and TEE probes within the limits defined by the PCCP.

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- Implementation of PCCP Modifications:

Modifications under the PCCP are implemented only through controlled software releases.

- Before implementation, each modification under the PCCP is evaluated using predefined verification and validation procedures.
- A modification is implemented only if all applicable predefined performance requirements and acceptance criteria are met.

- Performance Requirements for PCCP Modifications

- Each modification implemented under the PCCP must maintain acceptable AI Cardiac Auto Doppler performance according to predefined verification and validation criteria.
- PCCP modifications are not implemented if testing identifies unacceptable performance degradation or an unresolved risk to safe and effective use.

- Notification of Implemented PCCP Modifications

- Users will be informed of PCCP modifications through software release notes, software version information, customer communications, updated labeling, or other appropriate product documentation.
- For each applicable software release, GE HealthCare will provide information describing the implemented modification, affected software version, and other relevant information, as appropriate.

- Clarity+ for 2D: Multiple SRI filter settings, ranging from zero to strong filtering made available to the user in real time with a Clarity+ control, the same as cleared on the reference device Vivid Pioneer (K251169). Clarity+ for 2D supports non-cardiac imaging and ICE imaging and helps suppress noise and graininess (speckles), typical for ultrasound imaging, while sharpening boundaries and tiny structures.

- Clarity + for 4D: A real-time processing/filtering technique that utilizes volumetric data vs traditional 2D-based filtering, which is similar to Clarity+ for 4D cleared on the reference device Vivid Pioneer (K251169), when configured with 4D ICE Catheters.

- Auto Tissue: A Real-time image processing algorithm for automatic gain optimization of B-mode images to help the user minimize manual gain and TGC adjustment, the same as cleared

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on the reference device Vivid Pioneer (K251169).

- **RadiantFlow**: Applies shading to regular 2D color flow imaging, the same as cleared on the reference device Vivid Pioneer (K251169).
- **LV Diastolic Function Tool**: Provides an on-console, guideline-supported decision tree that organizes the inputs commonly used to evaluate left-ventricular diastolic function, guides the operator to acquire missing measurements, and summarizes the intermediate states and conclusion directly on the ultrasound system.
- **Measurement Favorites**: Streamlines the measurement workflow by placing the most frequently used measurements directly on the touch panel. This reduces the number of user interactions by reducing the need to navigate through the measurement menu to locate commonly used measurements.
- **4D Auto LHQ**: Simultaneously performs 4D quantification of both left heart chambers in fewer clicks, making it easy to incorporate the 4D assessment of left heart function into everyday practice, the same as cleared on the reference device Vivid Pioneer (K251169).
- **Myocardial Work**: A semi-automated tool based on systolic blood pressure, MV and AV opening and closure times, and LV strain results from AFI LV, for quantification of left ventricular Work Index, Constructive Work, Wasted Work, and Work Efficiency, the same as the Myocardial Work tool first cleared on reference device Vivid E95 (K170823).
- **2 Click Crop**: Modifications to the predicate Dual Crop workflow tool in predicate device Vivid S70N (K223832), now allowing up to 3 parallel crop planes, the same as cleared on the reference device Vivid Pioneer (K251169).
- **Flexi Slice Improvement**: Improved 4D workflow in Flexi-Slice, including the ability to move a crop-plane independently from a reference 2D plane, new 3x1 layout, Dual Crop in Flexi-Slice, improved interaction with slices (improved caption range and interaction areas), double click to translate slices, same as cleared on the reference device Vivid Pioneer (K251169).
- **2-Click Align**: Functionality added for Improved 4D workflow to the predicate Flexi-Slice in predicate Vivid S70N (K223832), the same as cleared on the reference device Vivid Pioneer (K251169).
- **Flexi-Light**: Provides a type of visualization intended to

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enhance depth perception of 3D objects on a 2D monitor by use of advanced shadowing, reflection and shading algorithms in combination with depth rendering techniques, the same as first cleared on the reference device Vivid E95 (K181685).

- **Realtime 3D Color Flow, 2D Color Flow:** Changes to color-flow related velocity-dependent filtering, to spatial filtering, and to the adaptive correction of variations in the speed of sound, the same as cleared on the reference device Vivid Pioneer (K251169).
- **LAA Sizing Tool:** Used for tracing the Left Atrial Appendage lumen and for measuring basic parameters within the traced area, the same as cleared on reference device Vivid Pioneer (K251169). This semi-automated tracing tool allows users to quickly measure the landing zone for fast confirmation of device sizing.
- **LAA Device compression:** A manual measurement- and calculation tool that allows manual caliper measurements of the width and the length of the Left Atrial Appendage, calculating compression in percentage on a chosen LAA-closure device size. This helps with LAA device sizing and is the same as cleared on reference device Vivid Pioneer (K251169).
- **TSP Height:** Tool used to visualize and measure the distance between the mitral anulus and the tip of the catheter during guided transeptal puncture procedures, the same as on cleared on the reference device Vivid Pioneer (K251169). Help users quickly find the ideal puncture location according to the guideline of the ongoing interventional procedure, with just 2 clicks.
- **4D Auto TVQ:** A semi-automated tool for 4D visualization and quantification of the tricuspid valve annulus, leaflet morphology and dynamics with integrated 4D ColorFlow capabilities, the same as cleared on reference device Vivid Pioneer (K251169).
- **4D Auto MVQ:** Updated with 4D ColorFlow capabilities, and the same as cleared on reference device Vivid Pioneer (K251169).
- **Instant Store:** Background processing for storing images without impacting ongoing real time scanning, the same as cleared on reference device Vivid Pioneer (K251169).
- **PDF Export to PACS server:** (a.k.a DICOM Encapsulated PDF) Allows storing PDF reports in a DICOM/PACS server, the same as cleared on the reference device Vivid Pioneer

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(K251169).

- **EchoPilot Integrated Display**: Displays the automated report computed by EchoPilot software in the ViewPoint EchoPilot App, thus enabling AI-driven workflow that automates echo measurements and reports resulting in significant time saving.
- **Secure Wipe**: Admin user is allowed to securely delete all data on the device, including all Person Identifiable Information / Personal Health Information, the same as cleared on reference device Vivid Pioneer (K251169).
- **NTP Clock Sync**: Admin users are allowed to configure the system for automatic clock synchronization to a selected Network Time Protocol server, the same as cleared on reference device Vivid Pioneer (K251169).
- **eDelivery**: Enables downloading and installing of partial system updates (patches) of the Windows OS and application, made available from the GE HealthCare server.
- **Archive**: Both the patient archive and the operating system are encrypted.
- **Transportation Mode**: Enables the user to move the system around without performing a full shutdown of the system, similar as cleared on reference device Vivid Pioneer (K251169).
- **Battery Scan Mode**: Up to 60 minutes of battery life with a fully charged battery in use to supply power to the system. Allows users to conveniently and quickly start bedside echo exams in tight spaces where access to wall power is challenging, and in interventional labs where power may not be available nearby.
- **Power Saving Mode**: Designed to reduce energy consumption and support environmental policies (ESG). Monitors user activity on the ultrasound system. If no user input is detected for a certain, configurable, period of time, the system will go into one of the power-saving modes, depending on how long it has been idle for.
- **Standby Mode**: Similar to sleep mode as cleared on reference device Vivid iq (K243620). It helps reduce battery consumption and allows for longer time between battery charges.
- **ViewLabel**: Displayed on the image area top-right corner during live scanning and added when storing the images in DICOM environment. Users can revise or remove the view label per their discretion. View labels are only stored in the DICOM file if the view label is stable throughout the captured loop. Similar to

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Automatic View Recognition as cleared on reference device Vivid Pioneer (K251169).

- One-click probe switch: A simplified probe and preset selection workflow, allowing users to select a probe with just one click. The selected probe will be automatically set to the primary preset as defined in the Probe menu.

- Advanced Stream Server: Adds the support of streaming 4D Markers and Flexi-Slice plane orientation, similar as Stream Server as cleared on predicate device VividS70N (K223832).

- cSound Architecture

- Imaging Architecture

Software-based beamforming digitizes signals from each probe element and reconstructs images using high-performance compute, preserving more data for improved image formation.

- Adaptive Image Formation

Advanced processing adapts to patient anatomy and clinical needs, optimizing contrast, resolution, and tissue visualization, even in challenging cases.

- Consistent and Scalable Performance

A common cSound foundation across the Vivid portfolio ensures consistent imaging, with higher-end systems scaling to exceptional resolution, penetration, and advanced capabilities.

- System and Probe Synergy

Image quality is driven by the combination of probe technology (e4D, XD clear, Single Crystal), system design, and cSound processing, enhancing clarity and diagnostic confidence.

- DICOM Character Set: Support a broader set of DICOM character sets, enabling correct handling of patient names, demographics, and study-information in many international languages

# Accessories:

- Support for wireless adapter, Netgear A8000
- Addition of ICE RS-DLP Adapter
- Addition of Crystal ICE Cord-RS
- Addition of Gel warmer

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- Addition of Transend DVD writer
- Addition of UP-D899DC printer
- Compatibility with AcuNav Crystal Ultrasound Catheter (K233270) from SIEMENS Medical Solutions USA, Inc., and SOUNDSTAR CRYSTAL Ultrasound Catheter (K240050) from Biosense Webster Inc.. The clinical indications and modes on the proposed devices are the same as on the reference device Vivid iq (K243620)
- Compatibility with CARTO 3 Navigation and mapping device (K223733), and Nuvision NAV and Non-NAV Intra Cardiac Catheter (K241540), both from Biosense Webster Inc, part of Johnson&Johnson MedTech

# Summary of Non-Clinical Tests:

The device 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 conform with applicable medical device safety standards. The proposed Vivid Pioneer complies with voluntary standards:

- AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety, 2005/A2:2021
- AAMI TIR69:2017/(R2020) Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems
- IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.1, 2020
- IEC 60601-2-37, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within Risk Management Process, Fifth edition, 2018
- ISO 14971, Application of risk management to medical devices, 2019
- NEMA PS 3.1 - 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2024e
- IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related

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to medical diagnostic ultrasonic fields, Edition 2.1, 2017

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 materials and other patient contact materials are biocompatible.

# AI Cardiac Auto Doppler Summary of Testing:

Performance testing was conducted to verify the proposed AI Cardiac Auto Doppler when operating without ECG signals. The same verification test method was performed on the proposed devices to make sure the performance unchanged, and a separate testing dataset was used to verify the AI Cardiac Auto Doppler on the proposed devices when operating without ECG signals. The test methods and acceptance criteria were unchanged. The results demonstrated that the proposed AI Cardiac Auto Doppler meets the performance specifications under ECG-absent conditions and does not affect the safety and effectiveness. Summary of test statistics and other results, including acceptance criteria and information supporting the appropriateness of the characterized performance, are provided below. The AI Cardiac Auto Doppler feature utilizes 3 AI algorithms, AI Doppler Spectrum Cycle Detection, Tissue Doppler and Doppler Trace, which are referenced below.

# Testing dataset:

- Testing dataset representatives of standard clinical practices used to collect typical cardiac images in clinical environments were assessed by experts for accuracy.
- AI Doppler Spectrum Cycle Detection testing dataset included 3197 recordings from 816 individuals
- Tissue Doppler testing dataset included 1570 recordings from 235 individuals.

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- Doppler Trace testing dataset included 1628 recordings from 582 individuals.

Distribution of testing dataset (Demographics and Ultrasound System):

- Gender: Male and Female
- Age: Adult and Pediatric
- Ethnicity/Country: USA (several locations), Australia, France, Spain, Norway, Italy, Germany, Thailand, Philippines, China (several locations)
- Ultrasound Console(s): Vivid E80, Vivid E95, Vivid E9, Vivid IQ, Vivid S70, Vivid T9, Vivid Q, Vivid Pioneer, Vivid Explorer, Vivid Advanced, Vivid Focus
- Probe(s): 6Sc, 6Vc, 3Sc, 4Sc, 4Vc, 4V, M5S, 6S, M4S, M5Sc, M5S, 12S, 9VT, 6VT, 10T

Information about clinical subgroups and confounders present in the testing dataset:

- The algorithm performance was verified across a range of confounders: Ethnicity/Country (USA - several locations, Australia, France, Spain, Norway, Italy, Germany, Thailand, Philippines, China – several locations), wide range of Vivid consoles, wide range of probes.

Characterized performance:

- The verification requirement included a step to check for a feasibility score of more than 95%, as well as an expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter.

The total number of samples used for developing the AI Doppler Spectrum Cycle Detection model is 9607 recordings from 20 unique clinical sites (not used for testing dataset).

Information about equipment and protocols used to collect images:

- Development dataset included images obtained with the M5Sc, M5S, 4Vc, M4S, M3S probes on a variety of Vivid cardiovascular ultrasound systems (Vivid E80, Vivid E9, Vivid 7, Vivid IQ, Vivid T9, and Vivid S70N)

Information about how the reference standard was derived from the dataset (i.e. the “truthing” process): Ground truth annotations of the development and verification datasets were obtained as follows:

- In all Training, Validation, and Testing datasets, annotators performed manual measurements after assessing Doppler signal

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quality and ECG signal quality of curated images.

- Four cardiologists performed the annotations following US ASE based annotation guidelines.
- A review panel of five clinical experts provided feedback on the annotations which were corrected (as needed) until a consensus agreement was reached between the annotators and reviewers.

Description of how independence of test data from training data was ensured:

- The testing dataset is selected from independent clinical research institutions that have never been used for training and validation (tuning), ensuring the elimination of potential data leakage.

Summary of Clinical Tests:

The subject to this premarket submission, Vivid Explorer/Vivid Advanced/Vivid Focus, did not require clinical studies to support substantial equivalence.

Conclusion:

Based on the equipment design similarities, conformance to recognized performance standards, and performance testing, GE HealthCare considers the proposed devices Vivid Explorer/Vivid Advanced/Vivid Focus to be as safe, effective, and performs in a substantially equivalent manner as the predicate device Vivid S70N (K223832).