AX WORKSTATION

System, Image Processing, Radiological

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ax Workstation.

Pre-market Notification Details

Device IDK992073
510k NumberK992073
Device Name:AX WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
ContactRobert W Callahan
CorrespondentRobert W Callahan
SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-18
Decision Date1999-09-09
Summary:summary

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