K132378 is an FDA 510(k) clearance for the X-MIND UNITY. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by De Gotzen S.R.L. (Olgiate Olona, Varese, IT). The FDA issued a Cleared decision on May 30, 2014, 303 days after receiving the submission on July 31, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K132378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2013 |
| Decision Date | May 30, 2014 |
| Days to Decision | 303 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |