K160093 is an FDA 510(k) clearance for the RayStation. 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 April 8, 2016, 80 days after receiving the submission on January 19, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K160093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2016 |
| Decision Date | April 08, 2016 |
| Days to Decision | 80 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 |