ROTA CAMERA

Camera, Scintillation (gamma)

SIEMENS GAMMASONICS, INC.

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

Pre-market Notification Details

Device IDK811715
510k NumberK811715
Device Name:ROTA CAMERA
ClassificationCamera, Scintillation (gamma)
Applicant SIEMENS GAMMASONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-18
Decision Date1981-07-20

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