K141787 is an FDA 510(k) clearance for the SAGITTILT. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Orfit Industries NV (Fort Myers, US). The FDA issued a Cleared decision on August 7, 2014, 36 days after receiving the submission on July 2, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K141787 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2014 |
| Decision Date | August 07, 2014 |
| Days to Decision | 36 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 |