K111676 is an FDA 510(k) clearance for the APEX. This device is classified as a Block, Beam-shaping, Radiation Therapy (Class II - Special Controls, product code IXI).
Submitted by Elekta Limited (West Sussex, GB). The FDA issued a Cleared decision on September 30, 2011, 107 days after receiving the submission on June 15, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5710.
| 510(k) Number | K111676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2011 |
| Decision Date | September 30, 2011 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXI - Block, Beam-shaping, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5710 |