K200487 is an FDA 510(k) clearance for the RayCare 3.1. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by RaySearch Laboratories AB (PUBL) (Stockholm, SE). The FDA issued a Cleared decision on June 10, 2020, 104 days after receiving the submission on February 27, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K200487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2020 |
| Decision Date | June 10, 2020 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ - System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |