Cleared Traditional

K241949 - Digital Color Doppler Ultrasound System...

K241949 is the FDA 510(k) clearance for Digital Color Doppler Ultrasound System... by Sonoscape Medical Corp.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K241949 · Sonoscape Medical Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
198d
Days
Class 2
Risk

K241949 is an FDA 510(k) clearance for the Digital Color Doppler Ultrasound System (P60 Series). 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 January 17, 2025 after a review of 198 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 K241949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2024
Decision Date January 17, 2025
Days to Decision 198 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
91d slower than avg
Panel avg: 107d · This submission: 198d
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 K241949.
Vivid iq
K243620 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025
Vivid T9/Vivid T8
K243628 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025
EPIQ Series Diagnostic Ultrasound System
K243794 · Philips Ultrasound, LLC · Feb 2025
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
K243502 · Olympus Medical Systems Corporation · Jan 2025
Voluson Expert 18
K242168 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 2024
ULTIMUS Series Ultrasound Diagnostic System
K240676 · Vinno Technology (Suzhou) Co.,Ltd · Dec 2024