Catalyst+, Catalyst+ HD

Accelerator, Linear, Medical

C-Rad Positioning AB

The following data is part of a premarket notification filed by C-rad Positioning Ab with the FDA for Catalyst+, Catalyst+ Hd.

Pre-market Notification Details

Device IDK200435
510k NumberK200435
Device Name:Catalyst+, Catalyst+ HD
ClassificationAccelerator, Linear, Medical
Applicant C-Rad Positioning AB Bredgränd 18 Uppsala,  SE 75320
ContactThomas Matzen
CorrespondentThomas Matzen
C-Rad Positioning AB Bredgränd 18 Uppsala,  SE 75320
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-05-07

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