The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Rotograph Prime 3d (under Trade Mark Villa Sistemi Medicali), I-max 3d (under Trade Mark Owandy Radiology).
| Device ID | K180601 |
| 510k Number | K180601 |
| Device Name: | Rotograph Prime 3D (under Trade Mark Villa Sistemi Medicali), I-MAX 3D (under Trade Mark Owandy Radiology) |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Villa Sistemi Medicali S.p.A. via Delle Azalee 3 Buccinasco, IT I-20090 |
| Contact | Paolo Casagrande Santin |
| Correspondent | Paolo Casagrande Santin Villa Sistemi Medicali S.p.A. via Delle Azalee 3 Buccinasco, IT I-20090 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-07 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052870660022 | K180601 | 000 |