K161984 is an FDA 510(k) clearance for the Interlocked Circular Small Field Collimators, Elekta Integrated. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Aktina Medical Corporation (Congers, US). The FDA issued a Cleared decision on September 27, 2016, 70 days after receiving the submission on July 19, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K161984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2016 |
| Decision Date | September 27, 2016 |
| Days to Decision | 70 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 |