Cleared Traditional

FLEXART V3.5 SOFTWARE (K970573) - FDA 510(k) Clearance

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

K970573 · Toshiba America Mri, Inc. · Radiology device
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Jul 1997
Decision
157d
Days
Class 2
Risk

K970573 is an FDA 510(k) clearance for the FLEXART V3.5 SOFTWARE. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Mri, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on July 21, 1997 after a review of 157 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 Toshiba America Mri, Inc. devices

Submission Details

510(k) Number K970573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1997
Decision Date July 21, 1997
Days to Decision 157 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
50d slower than avg
Panel avg: 107d · This submission: 157d
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 K970573.
ASSET APOLLO
K971884 · Philips Medical Systems (Cleveland), Inc. · Aug 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684 · Siemens Medical Solutions USA, Inc. · Aug 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668 · GE Medical Systems · Jul 1997
MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE
K965068 · Toshiba America Medical Systems, In.C · Jul 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
K971055 · Siemens Medical Solutions USA, Inc. · Jun 1997
MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)
K970852 · Siemens Medical Solutions USA, Inc. · Jun 1997