K230140 is an FDA 510(k) clearance for the TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US). This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Compai Healthcare (Suzhou) Co.,Ltd (Suzhou, CN). The FDA issued a Cleared decision on April 24, 2023, 96 days after receiving the submission on January 18, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K230140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2023 |
| Decision Date | April 24, 2023 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MWP — Cabinet, X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |