Aplio I900/i800/i700 Diagnostic Ultrasound System, Software V5.1

System, Imaging, Pulsed Doppler, Ultrasonic

Canon Medical Systems Corporation

The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aplio I900/i800/i700 Diagnostic Ultrasound System, Software V5.1.

Pre-market Notification Details

Device IDK201972
510k NumberK201972
Device Name:Aplio I900/i800/i700 Diagnostic Ultrasound System, Software V5.1
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentOrlando Tadeo
Canon Medical Systems USA, 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 Received2020-07-15
Decision Date2020-10-08

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