K202713 is an FDA 510(k) clearance for the TrueView 100 Pro. This device is classified as a Cabinet, X-ray System (Class II - Special Controls, product code MWP).
Submitted by Compai Healthcare (Shenzhen) Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on November 18, 2020, 63 days after receiving the submission on September 16, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K202713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2020 |
| Decision Date | November 18, 2020 |
| Days to Decision | 63 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 |