K162355 is an FDA 510(k) clearance for the Raycast MammoRx Carbon Fibre Breast Board. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Orfit Industries NV (Wijnegem, BE). The FDA issued a Cleared decision on November 22, 2016, 91 days after receiving the submission on August 23, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K162355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2016 |
| Decision Date | November 22, 2016 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYE - Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |