Aplio I900/i800/i700 Diagnostic Ultrasound System, V2.0

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 I900/i800/i700 Diagnostic Ultrasound System, V2.0.

Pre-market Notification Details

Device IDK161843
510k NumberK161843
Device Name:Aplio I900/i800/i700 Diagnostic Ultrasound System, V2.0
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentOrlando Tadeo
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 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 Received2016-07-05
Decision Date2016-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670102523 K161843 000
04987670102516 K161843 000
04987670102509 K161843 000
04987670004506 K161843 000
04987670004490 K161843 000
04987670004483 K161843 000
04987670004476 K161843 000
04987670004469 K161843 000
04987670004452 K161843 000

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