K052422 is an FDA 510(k) clearance for the THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE). This device is classified as a Unit, X-ray, Intraoral (Class II - Special Controls, product code EAP).
Submitted by Flow X-Ray Corp. (Great Neck, US). The FDA issued a Cleared decision on September 27, 2005, 25 days after receiving the submission on September 2, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1810.
| 510(k) Number | K052422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2005 |
| Decision Date | September 27, 2005 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EAP — Unit, X-ray, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1810 |