K232298 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Canon, Inc. (Kawasaki, JP). The FDA issued a Cleared decision on April 26, 2024, 269 days after receiving the submission on August 1, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K232298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2023 |
| Decision Date | April 26, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |