APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

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 Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK110870
510k NumberK110870
Device Name:APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
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 CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-29
Decision Date2011-10-04
Summary:summary

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