PCA-8000A, MARK 11, PET / CT SYSTEM

System, Tomography, Computed, Emission

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 Pca-8000a, Mark 11, Pet / Ct System.

Pre-market Notification Details

Device IDK082244
510k NumberK082244
Device Name:PCA-8000A, MARK 11, PET / CT SYSTEM
ClassificationSystem, Tomography, Computed, Emission
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 CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-08-08
Decision Date2008-08-21
Summary:summary

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