Cleared Traditional

K243628 - Vivid T9/Vivid T8

K243628 is an FDA 510(k) clearance for Vivid T9/Vivid T8, manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K243628 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology device
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Feb 2025
Decision
78d
Days
Class 2
Risk

K243628 is an FDA 510(k) clearance for the Vivid T9/Vivid T8. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on February 11, 2025 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems Ultrasound and Primary Care Diagnostics devices

FDA 510(k) Submission Details - K243628

510(k) Number K243628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2024
Decision Date February 11, 2025
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1091
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K243628.
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
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