K010464 is an FDA 510(k) clearance for the RADCALC, MODEL V.4.0. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Lifeline Software, Inc. (Tyler, US). The FDA issued a Cleared decision on May 17, 2001, 90 days after receiving the submission on February 16, 2001.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K010464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2001 |
| Decision Date | May 17, 2001 |
| Days to Decision | 90 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 |