Cleared Traditional

MAGNA SL (K940894) - FDA 510(k) Clearance

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

K940894 · Magna-Lab, Inc. · Radiology device
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Sep 1994
Decision
190d
Days
Class 2
Risk

K940894 is an FDA 510(k) clearance for the MAGNA SL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Magna-Lab, Inc. (Hicksville, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 190 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 Magna-Lab, Inc. devices

Submission Details

510(k) Number K940894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1994
Decision Date September 02, 1994
Days to Decision 190 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
83d slower than avg
Panel avg: 107d · This submission: 190d
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 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K940894.
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
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MERIT (O.1T MR SYSTEM)
K943415 · Philips Medical Systems (Cleveland), Inc. · Dec 1994
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
CP BODY ARRAY/ CP SPINE ARRAY COIL
K935627 · Siemens Medical Solutions USA, Inc. · Mar 1994