The following data is part of a premarket notification filed by Raysearch Laboratories Ab (publ) with the FDA for Raystation 11b.
| Device ID | K220141 |
| 510k Number | K220141 |
| Device Name: | RayStation 11B |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | RaySearch Laboratories AB (publ) Eugeniavägen 18 Stockholm, SE 113 68 |
| Contact | David Hedfors |
| Correspondent | David Hedfors RaySearch Laboratories AB (publ) Eugeniavägen 18 Stockholm, SE 113 68 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350002010570 | K220141 | 000 |