ASTEION CT SCANNER, TSX-021A

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 Asteion Ct Scanner, Tsx-021a.

Pre-market Notification Details

Device IDK982787
510k NumberK982787
Device Name:ASTEION CT SCANNER, TSX-021A
ClassificationSystem, X-ray, Tomography, Computed
Applicant TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
ContactPaul Biggins
CorrespondentPaul Biggins
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin,  CA  92781 -2068
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-10
Decision Date1998-10-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.