Cleared Traditional

PHILIPS GYROSCAN TN 15 (K932645) - FDA 510(k) Clearance

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

K932645 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
194d
Days
Class 2
Risk

K932645 is an FDA 510(k) clearance for the PHILIPS GYROSCAN TN 15. 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 December 13, 1993 after a review of 194 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 Philips Medical Systems, Inc. devices

Submission Details

510(k) Number K932645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date December 13, 1993
Days to Decision 194 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
87d slower than avg
Panel avg: 107d · This submission: 194d
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 471
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K932645.
MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016
K932271 · Siemens Medical Solutions USA, Inc. · Jan 1994
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K934499 · GE Medical Systems · Dec 1993
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