The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Strato X.
| Device ID | K002432 |
| 510k Number | K002432 |
| Device Name: | STRATO X |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Contact | Jeff Moeller |
| Correspondent | Jeff Moeller VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-08 |
| Decision Date | 2000-09-01 |