Cleared Traditional

K002522 - OPART

K002522 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 71-day FDA review.

K002522 · Toshiba America Mri, Inc. · Radiology device
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Oct 2000
Decision
71d
Days
Class 2
Risk

K002522 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 October 25, 2000 after a review of 71 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 K002522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date October 25, 2000
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
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 K002522.
QWH-149 WRIST ARRAY COIL
K003331 · Mri Devices Corp. · Nov 2000
OBC-149 BREAST ARRAY COIL
K003340 · Mri Devices Corp. · Nov 2000
POWER 5000 GENERAL PURPOSE COIL
K002483 · Usa Instruments, Inc. · Oct 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · Usa Instruments, Inc. · Oct 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · Mri Devices Corp. · Sep 2000
NEUROVASCULAR ARRAY COIL
K001946 · Ge Medical Systems, Inc. · Aug 2000