K200726 is an FDA 510(k) clearance for the AcuityPDR. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Radmedix, LLC (Dayton, US). The FDA issued a Cleared decision on April 13, 2020, 24 days after receiving the submission on March 20, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K200726 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2020 |
| Decision Date | April 13, 2020 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL - System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |