Cleared Traditional

K000549 - OPART

K000549 is the FDA 510(k) clearance for OPART by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K000549 · Toshiba America Mri, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
62d
Days
Class 2
Risk

K000549 is an FDA 510(k) clearance for the OPART, MODEL MRT-600. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Toshiba America Mri, Inc. (S. San Francisco, US). The FDA issued a Cleared decision on April 20, 2000 after a review of 62 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 K000549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date April 20, 2000
Days to Decision 62 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
45d faster than avg
Panel avg: 107d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K000549.
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INTERVENTIONAL BODY COIL
K000437 · Usa Instruments, Inc. · Apr 2000
MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES
K000345 · Medical Advances, Inc. · Apr 2000
KFA-63 KNEE AND FOOT ARRAY
K000935 · Mri Devices Corp. · Apr 2000