K233719 is an FDA 510(k) clearance for the FDR Visionary Suite. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Shimadzu Corporation (Kyoto, JP). The FDA issued a Cleared decision on March 28, 2024, 128 days after receiving the submission on November 21, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K233719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2023 |
| Decision Date | March 28, 2024 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |