The following data is part of a premarket notification filed by Raysearch Laboratories Ab (publ) with the FDA for Raycare 3.1.
| Device ID | K200487 |
| 510k Number | K200487 |
| Device Name: | RayCare 3.1 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm, SE 11134 |
| Contact | Viktoria Hammarstedt |
| Correspondent | Viktoria Hammarstedt RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm, SE 11134 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-27 |
| Decision Date | 2020-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350002010341 | K200487 | 000 |
| 07350002010419 | K200487 | 000 |
| 07350002010396 | K200487 | 000 |
| 07350002010358 | K200487 | 000 |
| 07350002010532 | K200487 | 000 |
| 07350002010280 | K200487 | 000 |
| 07350002010464 | K200487 | 000 |