SCENARIA Phase 3 Whole-body X-ray CT System

System, X-ray, Tomography, Computed

HITACHI MEDICAL SYSTEMS AMERICA, INC.

The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Scenaria Phase 3 Whole-body X-ray Ct System.

Pre-market Notification Details

Device IDK150595
510k NumberK150595
Device Name:SCENARIA Phase 3 Whole-body X-ray CT System
ClassificationSystem, X-ray, Tomography, Computed
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
ContactDoug Thistlethwaite
CorrespondentDoug Thistlethwaite
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-09
Decision Date2015-10-30
Summary:summary

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