Cleared Traditional

K983110 - FLEXART,FLEXART/HYPER, VISART, VISART/HYPER

K983110 is an FDA 510(k) clearance for FLEXART, manufactured by Toshiba America Mri, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K983110

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.

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 996
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