Cleared Traditional

K942875 - MODEL #900TO3500 HEAD/NECK COIL

K942875 is an FDA 510(k) clearance for MODEL #900TO3500 HEAD/NECK COIL, manufactured by Medic, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K942875 · Medic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
168d
Days
Class 2
Risk

K942875 is an FDA 510(k) clearance for the MODEL #900TO3500 HEAD/NECK COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Medic, Inc. (Fremont, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medic, Inc. devices

FDA 510(k) Submission Details - K942875

510(k) Number K942875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1994
Decision Date December 02, 1994
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 946
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K942875.
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K944112 · GE Medical Systems · Dec 1994
MERIT (O.1T MR SYSTEM)
K943415 · Philips Medical Systems (Cleveland), Inc. · Dec 1994
VERSION 5 OPERATING SYSTEM SOFTWARE
K943799 · Hitachi Medical Systems America, Inc. · Dec 1994
HEAD AND NECK COIL FOR THE GYREX 2T-DLX
K943320 · Elscint, Inc. · Nov 1994
GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)
K940534 · Philips Medical Systems, Inc. · Nov 1994
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
K940541 · Siemens Medical Solutions USA, Inc. · Nov 1994