APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0

System, Imaging, Pulsed Doppler, Ultrasonic

TOSHIBA MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aplio 500/400/300 Diagnostic Ultrasound System V4.0.

Pre-market Notification Details

Device IDK133761
510k NumberK133761
Device Name:APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin,  CA  92780
ContactCharlemagne Chua
CorrespondentCharlemagne Chua
TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin,  CA  92780
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-11
Decision Date2014-04-22
Summary:summary

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