FAN BEAM COLLIMATOR

Camera, Scintillation (gamma)

SIEMENS GAMMASONICS, INC.

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

Pre-market Notification Details

Device IDK933256
510k NumberK933256
Device Name:FAN BEAM COLLIMATOR
ClassificationCamera, Scintillation (gamma)
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 CodeIYX  
CFR Regulation Number892.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-06
Decision Date1993-10-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.