Cleared Traditional

GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE) (K940534) - FDA 510(k) Clearance

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

K940534 · Philips Medical Systems, Inc. · Radiology device
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Nov 1994
Decision
288d
Days
Class 2
Risk

K940534 is an FDA 510(k) clearance for the GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE). Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 288 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 K940534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date November 22, 1994
Days to Decision 288 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
181d slower than avg
Panel avg: 107d · This submission: 288d
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 K940534.
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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