SIENET CAMERA SERVER

System, Digital Image Communications, Radiological

SIEMENS GAMMASONICS, INC.

The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Sienet Camera Server.

Pre-market Notification Details

Device IDK923582
510k NumberK923582
Device Name:SIENET CAMERA SERVER
ClassificationSystem, Digital Image Communications, Radiological
Applicant SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
ContactIrena Krutulis
CorrespondentIrena Krutulis
SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
Product CodeLMD  
CFR Regulation Number892.2020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-20
Decision Date1992-10-14

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