CATALYST

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.

Pre-market Notification Details

• Device ID: K113276
• 510k Number: K113276
• Device Name: CATALYST
• Classification: Accelerator, Linear, Medical
• Applicant: C-RAD POSITIONING AB BREDGRAND 18 Uppsala, SE 75320
• Contact: Janina Ostling
• Correspondent: Janina Ostling; C-RAD POSITIONING AB BREDGRAND 18 Uppsala, SE 75320
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-11-07
• Decision Date: 2012-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07350005280024	K113276	000