CSCS-001A CALCIUM SCORING PACKAGE

System, X-ray, Tomography, Computed

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 Cscs-001a Calcium Scoring Package.

Pre-market Notification Details

Device IDK072737
510k NumberK072737
Device Name:CSCS-001A CALCIUM SCORING PACKAGE
ClassificationSystem, X-ray, Tomography, Computed
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
ContactPaul Biggins
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-09-27
Decision Date2007-10-05
Summary:summary

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