Cleared Traditional

PHILIPS MRI BREAST COIL (K926275) - FDA 510(k) Clearance

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

K926275 · Philips Medical Systems, Inc. · Radiology device
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Oct 1993
Decision
318d
Days
Class 2
Risk

K926275 is an FDA 510(k) clearance for the PHILIPS MRI BREAST COIL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on October 28, 1993 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K926275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date October 28, 1993
Days to Decision 318 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
211d slower than avg
Panel avg: 107d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 461
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K926275.
MERIT
K933356 · Philips Medical Systems (Cleveland), Inc. · Dec 1993
1.5T EDGE AND 1.0T VISTA SYSTEMS
K931544 · Philips Medical Systems (Cleveland), Inc. · Nov 1993
0.5T ASSET SYSTEM
K933835 · Philips Medical Systems (Cleveland), Inc. · Nov 1993
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
K932344 · Siemens Medical Solutions USA, Inc. · Oct 1993
EDGE SYSTEM
K932693 · Philips Medical Systems (Cleveland), Inc. · Oct 1993
MODIFIED BODY HELMHOLTZ COIL
K930811 · Siemens Medical Solutions USA, Inc. · Sep 1993