Sentinel

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 Sentinel.

Pre-market Notification Details

• Device ID: K200600
• 510k Number: K200600
• Device Name: Sentinel
• Classification: Accelerator, Linear, Medical
• Applicant: C-Rad Positioning AB Bredgränd 18 Uppsala, SE 75320
• Contact: Thomas Matzen
• Correspondent: Thomas Matzen; C-Rad Positioning AB Bredgränd 18 Uppsala, SE 75320
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-09
• Decision Date: 2020-04-20