Cleared Traditional

K991057 - EXTRA LARGE BODY COIL FOR OPART (MRT-600)

K991057 is the FDA 510(k) clearance for EXTRA LARGE BODY COIL FOR OPART (MRT-600) by Toshiba America Mri, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K991057 · Toshiba America Mri, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
51d
Days
Class 2
Risk

K991057 is an FDA 510(k) clearance for the EXTRA LARGE BODY COIL FOR OPART (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 May 20, 1999 after a review of 51 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 K991057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1999
Decision Date May 20, 1999
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
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 K991057.
QUADRATURE WRIST COIL, MODEL 445PH-64
K991434 · Medical Advances, Inc. · Jul 1999
`INEAR WRIST COIL, MODEL 440GE-09
K991113 · Medical Advances, Inc. · Jun 1999
LINEAR SHOULDER COIL, MODEL 414GE-09
K991115 · Medical Advances, Inc. · Jun 1999
OPART, MODEL MRT-600
K990007 · Toshiba America Mri, Inc. · Apr 1999
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
K983139 · GE Medical Systems · Feb 1999
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588 · Philips Medical Systems (Cleveland), Inc. · Feb 1999