Arietta 65

System, Imaging, Pulsed Doppler, Ultrasonic

Hitachi Healthcare Americas

The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Arietta 65.

Pre-market Notification Details

Device IDK202422
510k NumberK202422
Device Name:Arietta 65
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg,  OH  44087
ContactAaron Pierce
CorrespondentAaron Pierce
Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg,  OH  44087
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-24
Decision Date2020-11-04

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