K082582 is an FDA 510(k) clearance for the SENTINEL, MODEL SP-001. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by C-Rad Positioning AB (Uppsala, SE). The FDA issued a Cleared decision on March 30, 2009, 203 days after receiving the submission on September 8, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K082582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2008 |
| Decision Date | March 30, 2009 |
| Days to Decision | 203 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 |