ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A

Coil, Magnetic Resonance, Specialty

TOSHIBA AMERICA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Atlas Speeder Head/cervical Coil, Model Mjah-137a.

Pre-market Notification Details

Device IDK083014
510k NumberK083014
Device Name:ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
ClassificationCoil, Magnetic Resonance, Specialty
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR Tustin,  CA  92780
ContactPaul Biggins
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-10-09
Decision Date2008-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670102707 K083014 000

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