Cleared Traditional

K081322 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL

K081322 is an FDA 510(k) clearance for MAGNETIC RESONANCE DIAGNOSTIC DEVICE, manufactured by Shanghai Chenguang Medical Technologies Co, Ltd.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K081322 · Shanghai Chenguang Medical Technologies Co, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
37d
Days
Class 2
Risk

K081322 is an FDA 510(k) clearance for the MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE .... Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Shanghai Chenguang Medical Technologies Co, Ltd. (Flintville, US). The FDA issued a Cleared decision on June 18, 2008 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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.

FDA 510(k) Submission Details - K081322

510(k) Number K081322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2008
Decision Date June 18, 2008
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
Combination Product No
PCCP Authorized No
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.

MOS Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - MOS Coil, Magnetic Resonance, Specialty

All 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K081322.
NORAS MR-BI320-PA 3T
K082373 · Noras Mri Products GmbH · Aug 2008
ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
K081745 · Hitachi Medical Systems America, Inc. · Aug 2008
ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
K081198 · Hitachi Medical Systems America, Inc. · Jun 2008
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
K081340 · Shanghai Chenguang Medical Technologies Co, Ltd. · Jun 2008
NORAS MR-BI320-PA 1.5T
K081118 · Noras Mri Products GmbH · May 2008
TEM 3002G- HN DUAL TUNE HEAD COIL
K080820 · Mr Instruments, Inc. · Apr 2008
K081322 · MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
Download PDF FDA Summary Shanghai Chenguang Me…