Cleared Traditional

K920791 - GYROSCAN S15/ACS-II

K920791 is an FDA 510(k) clearance for GYROSCAN S15/ACS-II, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K920791 · Philips Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
259d
Days
Class 2
Risk

K920791 is an FDA 510(k) clearance for the GYROSCAN S15/ACS-II. 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 November 6, 1992 after a review of 259 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

FDA 510(k) Submission Details - K920791

510(k) Number K920791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1992
Decision Date November 06, 1992
Days to Decision 259 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
152d slower than avg
Panel avg: 107d · This submission: 259d
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 977
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K920791.
MRT-35(TM)
K921940 · Toshiba America Mri, Inc. · Nov 1992
SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT
K921941 · General Electric Co. · Nov 1992
PHILIPS GYROSCAN T5 SERIES II
K920578 · Philips Medical Systems North America, Inc. · Nov 1992
3D IMAGING
K923823 · Resonex, Inc. · Oct 1992
A BREAST COIL FOR THE GYREX 2T-DIX
K923897 · Elscint, Inc. · Oct 1992
VISTA HPQ SYSTEM
K923615 · Philips Medical Systems (Cleveland), Inc. · Oct 1992