Cleared Traditional

K121867 - SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND ...

K121867 is the FDA 510(k) clearance for SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND ... by Chison Medical Imaging Co., Ltd.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K121867 · Chison Medical Imaging Co., Ltd. · Radiology device
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Aug 2012
Decision
37d
Days
Class 2
Risk

K121867 is an FDA 510(k) clearance for the SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS. 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 Chison Medical Imaging Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 2, 2012 after a review of 37 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 Chison Medical Imaging Co., Ltd. devices

Submission Details

510(k) Number K121867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2012
Decision Date August 02, 2012
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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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