The following data is part of a premarket notification filed by C-rad Positioning Ab with the FDA for Sentinel, Model Sp-001.
| Device ID | K082582 |
| 510k Number | K082582 |
| Device Name: | SENTINEL, MODEL SP-001 |
| Classification | Accelerator, Linear, Medical |
| Applicant | C-RAD POSITIONING AB BREDGRAND 14 Uppsala, SE 75320 |
| Contact | Cristina Svensson |
| Correspondent | Cristina Svensson C-RAD POSITIONING AB BREDGRAND 14 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 | 2008-09-08 |
| Decision Date | 2009-03-30 |
| Summary: | summary |