The following data is part of a premarket notification filed by C-rad Positioning Ab with the FDA for Catalyst+, Catalyst+ Hd.
| Device ID | K200435 |
| 510k Number | K200435 |
| Device Name: | Catalyst+, Catalyst+ HD |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-24 |
| Decision Date | 2020-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350005280045 | K200435 | 000 |
| 17350005280038 | K200435 | 000 |