K111759 is an FDA 510(k) clearance for the .DECIMAL ELECTRON APERTURE. This device is classified as a Block, Beam-shaping, Radiation Therapy (Class II - Special Controls, product code IXI).
Submitted by .Decimal, Inc. (Sanford, US). The FDA issued a Cleared decision on September 9, 2011, 79 days after receiving the submission on June 22, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5710.
| 510(k) Number | K111759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2011 |
| Decision Date | September 09, 2011 |
| Days to Decision | 79 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 |