Cleared Traditional

K920199 - HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST

K920199 is an FDA 510(k) clearance for HEAD COIL GEOMETRIC DISTOR SPEC FOR VIS..., manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K920199

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.

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 1109
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K920199.
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K920199 · HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST
Download PDF FDA Summary Philips Medical Syste…