The following data is part of a premarket notification filed by Raysearch Laboratories Ab (publ) with the FDA for Raycare 2.3.
| Device ID | K191384 |
| 510k Number | K191384 |
| Device Name: | RayCare 2.3 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | RaySearch Laboratories AB (publ) Sveavagen 44 Stockholm, SE 11134 |
| Contact | David Hedfors |
| Correspondent | David Hedfors RaySearch Laboratories AB (publ) Sveavagen 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 | 2019-05-23 |
| Decision Date | 2019-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350002010259 | K191384 | 000 |
| 07350002010181 | K191384 | 000 |
| 07350002010198 | K191384 | 000 |