Aplio A550 And A450, Software V2.8 Diagnostic Ultrasound System

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 A550 And A450, Software V2.8 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK182427
510k NumberK182427
Device Name:Aplio A550 And A450, Software V2.8 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi,  JP 324-8550
ContactPaul Biggins
CorrespondentOrlando Tadeo Jr
Canon 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 Received2018-09-06
Decision Date2018-11-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04987670103353 K182427 000
04987670103346 K182427 000

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