Cleared Traditional

K965068 - MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE

K965068 is an FDA 510(k) clearance for MAGNETIC RESONANC DVCE VISART V 3.5 SOF..., manufactured by Toshiba America Medical Systems, In.C. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K965068 · Toshiba America Medical Systems, In.C · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
209d
Days
Class 2
Risk

K965068 is an FDA 510(k) clearance for the MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Toshiba America Medical Systems, In.C (Tustin, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 209 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 Medical Systems, In.C devices

FDA 510(k) Submission Details - K965068

510(k) Number K965068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date July 15, 1997
Days to Decision 209 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
102d slower than avg
Panel avg: 107d · This submission: 209d
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 967
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K965068.
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
FLEXART V3.5 SOFTWARE
K970573 · Toshiba America Mri, Inc. · Jul 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
K971279 · Hitachi Medical Systems America, Inc. · Jul 1997
MEDRAD FLEX INTERFACE DEVICE
K971380 · Medrad, Inc. · Jul 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
K971055 · Siemens Medical Solutions USA, Inc. · Jun 1997