The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Vision R/f Tilting Table.
| Device ID | K000412 |
| 510k Number | K000412 |
| Device Name: | VISION R/F TILTING TABLE |
| Classification | Table, Radiographic, Tilting |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Contact | Jeffery N Moeller |
| Correspondent | Jeffery N Moeller VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-08 |
| Decision Date | 2000-04-24 |