Cleared Traditional

K130801 - DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

K130801 is an FDA 510(k) clearance for DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, manufactured by Sonoscape Company Limited. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K130801 · Sonoscape Company Limited · Radiology device
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Jun 2013
Decision
84d
Days
Class 2
Risk

K130801 is an FDA 510(k) clearance for the 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 Company Limited (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on June 14, 2013 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sonoscape Company Limited devices

FDA 510(k) Submission Details - K130801

510(k) Number K130801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2013
Decision Date June 14, 2013
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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 891
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