Cleared Traditional

ARTOSCAN M (K963262) - FDA 510(k) Clearance

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

K963262 · Biosound, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
220d
Days
Class 2
Risk

K963262 is an FDA 510(k) clearance for the ARTOSCAN M. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 220 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 Biosound, Inc. devices

Submission Details

510(k) Number K963262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1996
Decision Date March 28, 1997
Days to Decision 220 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
113d slower than avg
Panel avg: 107d · This submission: 220d
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 485
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K963262.
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EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
K964626 · Philips Medical Systems (Cleveland), Inc. · Feb 1997
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K964306 · General Electric Co. · Jan 1997