The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Rotograph Evo 3d.
| Device ID | K111152 |
| 510k Number | K111152 |
| Device Name: | ROTOGRAPH EVO 3D |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090 |
| Contact | Paolo Casagrande Santin |
| Correspondent | Paolo Casagrande Santin VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-25 |
| Decision Date | 2011-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052870661012 | K111152 | 000 |