Cleared Traditional

K240676 - ULTIMUS Series Ultrasound Diagnostic System

K240676 is an FDA 510(k) clearance for ULTIMUS Series Ultrasound Diagnostic System, manufactured by Vinno Technology (Suzhou) Co.,Ltd. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K240676 · Vinno Technology (Suzhou) Co.,Ltd · Radiology device
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Dec 2024
Decision
280d
Days
Class 2
Risk

K240676 is an FDA 510(k) clearance for the ULTIMUS Series Ultrasound Diagnostic System. 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 Vinno Technology (Suzhou) Co.,Ltd (Suzhou, CN). The FDA issued a Cleared decision on December 16, 2024 after a review of 280 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vinno Technology (Suzhou) Co.,Ltd devices

FDA 510(k) Submission Details - K240676

510(k) Number K240676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2024
Decision Date December 16, 2024
Days to Decision 280 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
173d slower than avg
Panel avg: 107d · This submission: 280d
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 870
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K240676.
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