The following data is part of a premarket notification filed by Raysearch Laboratories Ab (publ) with the FDA for Raystation 7.
| Device ID | K180379 |
| 510k Number | K180379 |
| Device Name: | RayStation 7 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | RaySearch Laboratories AB (publ) Sveavagen 44 Stockholm, SE 111 34 |
| Contact | David Hedfors |
| Correspondent | David Hedfors RaySearch Laboratories AB (publ) Sveavagen 44 Stockholm, SE 111 34 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-12 |
| Decision Date | 2018-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350002010112 | K180379 | 000 |
| 07350002010068 | K180379 | 000 |