Cleared Traditional

K170856 - CMS600P2 B-Ultrasound Diagnostic System

K170856 is an FDA 510(k) clearance for CMS600P2 B-Ultrasound Diagnostic System, manufactured by Contec Medical Systems Co.,Ltd. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K170856 · Contec Medical Systems Co.,Ltd · Radiology device
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Nov 2017
Decision
240d
Days
Class 2
Risk

K170856 is an FDA 510(k) clearance for the CMS600P2 B-Ultrasound Diagnostic System. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on November 17, 2017 after a review of 240 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Contec Medical Systems Co.,Ltd devices

FDA 510(k) Submission Details - K170856

510(k) Number K170856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2017
Decision Date November 17, 2017
Days to Decision 240 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
133d slower than avg
Panel avg: 107d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Consultant

Beijing Believe Technology Service Co., Ltd.
Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 716
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K170856.
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