Cleared Traditional

PHILIPS ENDO-CAVITARY MRI COIL (K930193) - FDA 510(k) Clearance

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

K930193 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
526d
Days
Class 2
Risk

K930193 is an FDA 510(k) clearance for the PHILIPS ENDO-CAVITARY MRI 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 June 24, 1994 after a review of 526 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K930193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date June 24, 1994
Days to Decision 526 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
419d slower than avg
Panel avg: 107d · This submission: 526d
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 K930193.
MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)
K940541 · Siemens Medical Solutions USA, Inc. · Nov 1994
EDGE
K941996 · Philips Medical Systems (Cleveland), Inc. · Aug 1994
MERIT
K941408 · Philips Medical Systems (Cleveland), Inc. · Jul 1994
CP BODY ARRAY/ CP SPINE ARRAY COIL
K935627 · Siemens Medical Solutions USA, Inc. · Mar 1994
CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS
K935752 · Siemens Medical Solutions USA, Inc. · Mar 1994
MAGNETOM OPEN
K935661 · Siemens Medical Solutions USA, Inc. · Mar 1994