Cleared Special

K221911 - VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221911 · Vinno Technology (Suzhou) Co.,Ltd · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
174d
Days
Class 2
Risk

K221911 is an FDA 510(k) clearance for the VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP. 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 21, 2022 after a review of 174 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K221911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2022
Decision Date December 21, 2022
Days to Decision 174 days
Submission Type Special
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
67d slower than avg
Panel avg: 107d · This submission: 174d
Pathway characteristics
Modification to existing cleared device.

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

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