The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Explor-x 70.
| Device ID | K991310 |
| 510k Number | K991310 |
| Device Name: | EXPLOR-X 70 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. 219 MAYER AVE. Wheeling, IL 60090 |
| Contact | Al Sosa |
| Correspondent | Al Sosa VILLA SISTEMI MEDICALI S.P.A. 219 MAYER AVE. Wheeling, IL 60090 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-16 |
| Decision Date | 1999-06-18 |
| Summary: | summary |