Cleared Traditional

K241949 - Digital Color Doppler Ultrasound System (P60 Series) (FDA 510(k) Clearance)

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

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.