Radiology · 510(k) · 2025
Vivid T9/Vivid T8
GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared by FDA on 11 February 2025 under submission K243628, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K243628
- Device. Vivid T9/Vivid T8DEVICE
- Company. GE Medical Systems Ultrasound and Primary Care DiagnosticsCOMPANY
- Decision. 11 February 2025, 510(k), substantially equivalent (traditional review); received 25 November 2024DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
, however the proposed device Vivid T9/Vivid T8 is adding Vascular Access which has been cleared on reference devices Vivid S70N/S60N (K220619). Transducers: • The proposed Vivid T9/Vivid T8 and predicate Vivid T9/Vivid T8 (K221147) transducers are the same. • The clinical indications and modes on the proposed Vivid T9/Vivid T8 are the same as on the predicate device Vivid T9/Vivid T8 (K221147) 3 GE HealthCare 510(k) Premarket Notification Submission Software Features/Functionality: • Clarity +: similar to Advanced SRI-HD on cleared LOGIQ Fortis (K211524). It is a real-time image processing/filtering technique that suppresses noise and graininess (reduces speckles) while sharpening boundaries and small structures. • DICOM Encapsulated PDF reports: allows PDF reports generated on the system to be transferred through DICOM data flows and stored in DICOM storage, in accordance with the DICOM standard. • Remote Viewing: same as on cleared Vivid S70N/S60N(K220619), enables streaming of the main monitor over the local network. This feature is not for diagnostic use. • One-click QuickApps shortcuts: allows users to maintain high-quality tissue and blood flow visualization during transition between high flow / low flow and superficial / deep scanning with only one-click on the main screen. Accessories: • Additional wireless adapter Netgear A8000 • Additional Transend DVD writer
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionstriage or notification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2,748 reports filed against devices carrying product code IYN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · ACUSON Origin Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00096
30 September 2026 · Malfunction · ACUSON Sequoia Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00097
30 September 2026 · Malfunction · AFFINITI 30 · Philips Ultrasound, Inc · report 3019216-2026-100325
30 September 2026 · Injury · EPIQ 5G · Philips Ultrasound, Inc · report 3019216-2026-100326
29 September 2026 · Malfunction · ACUSON Juniper · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00091
One of the patient exams performed on the Juniper system displays an "Unarchived" error message and they are unable to send this study to PACS. All other exams performed before are after this one are transferring over to the PACS as expected without any errors. The problem occurred after a Breast study was completed and the user tried to send it over to the network PACS. TSE worked with the customer and she confirmed that the problem cannot be reproduced, as it only is affecting this one exam. […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code IYN, in Radiology, from GE Medical Systems Ultrasound and Primary Care Diagnostics, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.