The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Rotograph Prime (under Trade Mark Villa Sistemi Medicali), I-max (under Trade Mark Owandy Radiology).
| Device ID | K162190 |
| 510k Number | K162190 |
| Device Name: | Rotograph Prime (under Trade Mark Villa Sistemi Medicali), I-MAX (under Trade Mark Owandy Radiology) |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-04 |
| Decision Date | 2017-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052870660015 | K162190 | 000 |