K203374 is an FDA 510(k) clearance for the X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology). This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by De G?tzen S.R.L. (Olgiate Olona, IT). The FDA issued a Cleared decision on February 5, 2021, 81 days after receiving the submission on November 16, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K203374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2020 |
| Decision Date | February 05, 2021 |
| Days to Decision | 81 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |