The following data is part of a premarket notification filed by Radiotecnologia Industrial S.a. De C.v. with the FDA for Bi Image-x Evolution.
| Device ID | K160458 |
| 510k Number | K160458 |
| Device Name: | BI IMAGE-X EVOLUTION |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V. CALLE PUEBLA SUR, MANZANA 4 LOTE 5 COLONIA JARDIN INDUSTRIAL Ixtapaluca, MX 56535 |
| Contact | Marcelo Mojica |
| Correspondent | Claude Berthoin DENTERPRISE INTERNATIONAL, INC./ 510K FDA CONSULTING 100 EAST GRANADA BLVD SUITE 219 Ormond Beach, FL 32176 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D881RXEPWEXP0 | K160458 | 000 |
| D881RXEMWEXP0 | K160458 | 000 |