K183606 is an FDA 510(k) clearance for the Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW). This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Scandidos AB (Uppsala, SE). The FDA issued a Cleared decision on April 8, 2019, 103 days after receiving the submission on December 26, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K183606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2018 |
| Decision Date | April 08, 2019 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |