APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN

The following data is part of a premarket notification filed by Toshiba Medical Systems Coporation, Japan with the FDA for Aplio 500/400/300 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK121422
510k NumberK121422
Device Name:APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN 2441 MICHELLE DR Tustin,  CA  92780
ContactCharlemagne Chua
CorrespondentCharlemagne Chua
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN 2441 MICHELLE DR Tustin,  CA  92780
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-14
Decision Date2012-08-16
Summary:summary

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