Al-Rad Companion (Musculoskeletal)

System, X-ray, Tomography, Computed

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 Al-rad Companion (musculoskeletal).

Pre-market Notification Details

Device IDK193267
510k NumberK193267
Device Name:Al-Rad Companion (Musculoskeletal)
ClassificationSystem, X-ray, Tomography, Computed
Applicant Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
ContactAlaine Medio
CorrespondentAlaine Medio
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville,  TN  37932
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-03-16

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