The following data is part of a premarket notification filed by Edlen Imaging Llc with the FDA for X-view, Imagen.
| Device ID | K151137 |
| 510k Number | K151137 |
| Device Name: | X-VIEW, IMAGEN |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | EDLEN IMAGING LLC 16441 NORTH 91ST STREET SUITE 102 Scottsdale, AZ 85260 |
| Contact | Nick Radachi |
| Correspondent | Nick Radachi EDLEN IMAGING LLC 16441 NORTH 91ST STREET SUITE 102 Scottsdale, AZ 85260 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-29 |
| Decision Date | 2016-06-07 |
| Summary: | summary |