The following data is part of a premarket notification filed by Flow X-ray Corp. with the FDA for The Envision Intraoral Dental X-ray Machines (wall Mounted And Mobile).
| Device ID | K052422 |
| 510k Number | K052422 |
| Device Name: | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) |
| Classification | Unit, X-ray, Intraoral |
| Applicant | FLOW X-RAY CORP. 55 NORTHEREN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk FLOW X-RAY CORP. 55 NORTHEREN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-02 |
| Decision Date | 2005-09-27 |
| Summary: | summary |