Cleared Traditional

K040937 - TEM 3000 HEAD COIL

K040937 is the FDA 510(k) clearance for TEM 3000 HEAD COIL by Mr Instruments, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K040937 · Mr Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
11d
Days
Class 2
Risk

K040937 is an FDA 510(k) clearance for the TEM 3000 HEAD COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Mr Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 23, 2004 after a review of 11 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 Mr Instruments, Inc. devices

Submission Details

510(k) Number K040937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2004
Decision Date April 23, 2004
Days to Decision 11 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
96d faster than avg
Panel avg: 107d · This submission: 11d
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 300
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K040937.
MODEL BBC-127 BIOPSY BREAST COIL
K041481 · Mri Devices Corp. · Jul 2004
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
K041487 · Usa Instruments, Inc. · Jun 2004
MODIFICATION TO E-SCAN XQ MRI SYSTEM
K041145 · Esaote, S.P.A. · May 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348 · Mri Devices Corp. · Mar 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · Mri Devices Corp. · Mar 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288 · Mri Devices Corp. · Mar 2004