Cleared Traditional

MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH, (K071882) - FDA 510(k) Clearance

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

K071882 · Shanghai Chenguang Medical Technologies Co, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
9d
Days
Class 2
Risk

K071882 is an FDA 510(k) clearance for the MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Shanghai Chenguang Medical Technologies Co, Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 18, 2007 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Shanghai Chenguang Medical Technologies Co, Ltd. devices

Submission Details

510(k) Number K071882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date July 18, 2007
Days to Decision 9 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
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - MOS Coil, Magnetic Resonance, Specialty

All 77
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K071882.
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275 · Siemens Medical Solutions USA, Inc. · Jan 2011
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
K100141 · Siemens Medical Solutions USA, Inc. · Aug 2010
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · Siemens Medical Solutions USA, Inc. · Jan 2009
NORAS OR HEAD HOLDER
K071179 · Siemens Medical Solutions USA, Inc. · Jun 2007
OR HEAD COIL 1.5 T
K060758 · Siemens Medical Solutions USA, Inc. · May 2006
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617 · Siemens Medical Solutions USA, Inc. · Nov 2004