K232058 is an FDA 510(k) clearance for the YosemiteView 4343W/YosemiteView 3643W. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Careray Digital Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 3, 2023, 23 days after receiving the submission on July 11, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K232058 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2023 |
| Decision Date | August 03, 2023 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |