SCEPTRE-VS

System, Image Processing, Radiological

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 Sceptre-vs.

Pre-market Notification Details

Device IDK021314
510k NumberK021314
Device Name:SCEPTRE-VS
ClassificationSystem, Image Processing, Radiological
Applicant HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
ContactRobert H Mccarthy
CorrespondentRobert H Mccarthy
HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg,  OH  44087
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-25
Decision Date2002-07-02
Summary:summary

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