K231612 is an FDA 510(k) clearance for the Eve Patient Positioner System. This device is classified as a Couch, Radiation Therapy, Powered (Class II - Special Controls, product code JAI).
Submitted by Leo Cancer Care (Middleton, US). The FDA issued a Cleared decision on May 7, 2024, 340 days after receiving the submission on June 2, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5770.
| 510(k) Number | K231612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2023 |
| Decision Date | May 07, 2024 |
| Days to Decision | 340 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAI - Couch, Radiation Therapy, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5770 |