Cleared Traditional

K983110 - FLEXART

K983110 is the FDA 510(k) clearance for FLEXART by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K983110 · Toshiba America Mri, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
174d
Days
Class 2
Risk

K983110 is an FDA 510(k) clearance for the FLEXART,FLEXART/HYPER, VISART, VISART/HYPER. 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 February 25, 1999 after a review of 174 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 K983110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1998
Decision Date February 25, 1999
Days to Decision 174 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
67d slower than avg
Panel avg: 107d · This submission: 174d
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 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K983110.
EXCELART
K990620 · Toshiba America Mri, Inc. · May 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K990550 · Ge Medical Systems, Inc. · May 1999
OPART
K990260 · Toshiba America Mri, Inc. · Apr 1999
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
K984221 · Siemens Corp. · Feb 1999
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
K984280 · Hitachi Medical Systems America, Inc. · Feb 1999
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
K984224 · Siemens Corp. · Feb 1999