Cleared Traditional

K990620 - EXCELART

K990620 is the FDA 510(k) clearance for EXCELART by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K990620 · Toshiba America Mri, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
78d
Days
Class 2
Risk

K990620 is an FDA 510(k) clearance for the EXCELART. 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 May 14, 1999 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toshiba America Mri, Inc. devices

Submission Details

510(k) Number K990620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1999
Decision Date May 14, 1999
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 K990620.
MRGP OPTICAL TRACKING UNIT
K991943 · Philips Medical Systems (Cleveland), Inc. · Aug 1999
IPASS BOLUS TRACKING
K992412 · Philips Medical Systems (Cleveland), Inc. · Aug 1999
HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM
K991652 · Siemens Corp. · Aug 1999
3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
K990550 · Ge Medical Systems, Inc. · May 1999
OPART
K990260 · Toshiba America Mri, Inc. · Apr 1999
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
K983110 · Toshiba America Mri, Inc. · Feb 1999