Submission Details
| 510(k) Number | K231612 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
K231612 - Eve Patient Positioner System
(FDA 510(k) Clearance)
May 2024
Decision
340d
Days
Class 2
Risk
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.
Device Classification
| Product Code | JAI — Couch, Radiation Therapy, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.5770 |
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