Cleared Traditional

K222596 - S90 Exp Series Digital Color Doppler Ul...

K222596 is the FDA 510(k) clearance for S90 Exp Series Digital Color Doppler Ul... by Sonoscape Medical Corp.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K222596 · Sonoscape Medical Corp. · Radiology device
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Feb 2023
Decision
168d
Days
Class 2
Risk

K222596 is an FDA 510(k) clearance for the S90 Exp Series Digital Color Doppler Ultrasound 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 Sonoscape Medical Corp. (Shenzhen, CN). The FDA issued a Cleared decision on February 10, 2023 after a review of 168 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 Sonoscape Medical Corp. devices

Submission Details

510(k) Number K222596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2022
Decision Date February 10, 2023
Days to Decision 168 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
61d slower than avg
Panel avg: 107d · This submission: 168d
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 779
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K222596.
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