Cleared Traditional

K050167 - CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE

K050167 is an FDA 510(k) clearance for CHISON 600M WITH C60 CONVEX PROBE, manufactured by Chison Medical Imaging Co., Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K050167 · Chison Medical Imaging Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
13d
Days
Class 2
Risk

K050167 is an FDA 510(k) clearance for the CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Chison Medical Imaging Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on February 8, 2005 after a review of 13 days - a notably fast clearance 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: 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

FDA 510(k) Submission Details - K050167

510(k) Number K050167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date February 08, 2005
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Tuv Rheinland of North America, Inc.

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 649
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K050167.
PACHPEN PACHYMETER, MODEL 24-5100
K050552 · Accutome, Inc. · Mar 2005
VOYAGER PERSONAL IMAGING DEVICE
K050551 · Ardent Sound, Inc. · Mar 2005
SONALIS, MODEL 2000
K043189 · 3g Ultrasound, Inc. · Feb 2005
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K043563 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
SONATA 3-D IMAGING ACCESSORY, MODEL 3DS
K042620 · Tetrad Corp. · Dec 2004
PALMSCAN AP2000
K043287 · Micromedical Devices, Inc. · Dec 2004