Cleared Traditional

K080820 - TEM 3002G- HN DUAL TUNE HEAD COIL

K080820 is an FDA 510(k) clearance for TEM 3002G- HN DUAL TUNE HEAD COIL, manufactured by Mr Instruments, Inc.. The device is a Class 2 Radiology device with product code MOS cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K080820 · Mr Instruments, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
9d
Days
Class 2
Risk

K080820 is an FDA 510(k) clearance for the TEM 3002G- HN DUAL TUNE HEAD COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mr Instruments, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 2, 2008 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.

FDA 510(k) Submission Details - K080820

510(k) Number K080820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2008
Decision Date April 02, 2008
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
Combination Product No
PCCP Authorized No
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.

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 490
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K080820.
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
K081322 · Shanghai Chenguang Medical Technologies Co, Ltd. · 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
HFO SHOULDER COIL
K080120 · Philips Medical Systems MR Finland · Mar 2008
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
K080062 · Hitachi Medical Systems America, Inc. · Feb 2008
MICROMRI WRIST COIL
K073131 · Micromri, Inc. · Jan 2008
K080820 · TEM 3002G- HN DUAL TUNE HEAD COIL
Download PDF FDA Summary Mr Instruments, Inc.