K091911 is an FDA 510(k) clearance for the BOLUS COMPENSATOR. 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 July 21, 2009, 26 days after receiving the submission on June 25, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5710.
| 510(k) Number | K091911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2009 |
| Decision Date | July 21, 2009 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |