Cleared Traditional

K920199 - HEAD COIL GEOMETRIC DISTOR SPEC FOR VIS...

K920199 is the FDA 510(k) clearance for HEAD COIL GEOMETRIC DISTOR SPEC FOR VIS... by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K920199 · Philips Medical Systems (Cleveland), Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
51d
Days
Class 2
Risk

K920199 is an FDA 510(k) clearance for the HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on March 6, 1992 after a review of 51 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 Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K920199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1992
Decision Date March 06, 1992
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K920199.
MRT-50 FLEXIBLE BODY COIL
K920126 · Toshiba America Mri, Inc. · Apr 1992
MRT-50 QD HEAD COIL
K920097 · Toshiba America Mri, Inc. · Mar 1992
MRT-50 SPINE COIL
K920125 · Toshiba America Mri, Inc. · Mar 1992
MODEL 310GE-64: WHOLE VOLUME NECK COIL
K914209 · Medical Advances, Inc. · Mar 1992
MOBILE MRP-7000
K920159 · Hitachi Medical Systems America, Inc. · Mar 1992
3D PROCESSING OPTIONS FOR GYREX
K915579 · Elscint, Inc. · Feb 1992