Cleared Traditional

VINNO 8, VINNO 6, VINNO 5 (K190120) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190120 · Vinno Technology (Suzhou) Co.,Ltd · Radiology device
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Jan 2020
Decision
364d
Days
Class 2
Risk

K190120 is an FDA 510(k) clearance for the VINNO 8, VINNO 6, VINNO 5. 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 January 23, 2020 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K190120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2019
Decision Date January 23, 2020
Days to Decision 364 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
257d slower than avg
Panel avg: 107d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K190120.
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K192152 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2019