SCENARIA View

System, X-ray, Tomography, Computed

Hitachi Healthcare Americas

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

Pre-market Notification Details

Device IDK200498
510k NumberK200498
Device Name:SCENARIA View
ClassificationSystem, X-ray, Tomography, Computed
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 CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-28
Decision Date2020-07-17

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