K220582 is an FDA 510(k) clearance for the ClearCalc Model RADCA V2. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Radformation, Inc. (New York, US). The FDA issued a Cleared decision on August 22, 2022, 174 days after receiving the submission on March 1, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K220582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2022 |
| Decision Date | August 22, 2022 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ - System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |