LITEBOX DIAGNOSTIC REVIEW WORKSTATION

System, Image Processing, Radiological

SIEMENS GAMMASONICS, INC.

The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Litebox Diagnostic Review Workstation.

Pre-market Notification Details

Device IDK901158
510k NumberK901158
Device Name:LITEBOX DIAGNOSTIC REVIEW WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
ContactDennis W Henkelman
CorrespondentDennis W Henkelman
SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-13
Decision Date1990-04-19

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