The following data is part of a premarket notification filed by De Gotzen S.r.l. with the FDA for X-mind Prime 3d (under Trademark Acteon), I-max 3d (under Trademark Owandy Radiology).
| Device ID | K201382 |
| 510k Number | K201382 |
| Device Name: | X-MIND Prime 3D (under Trademark Acteon), I-MAX 3D (under Trademark Owandy Radiology) |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | de Gotzen S.r.l. Via Roma, 45 Olgiate Olona, IT 21057 |
| Contact | Dario Bandiera |
| Correspondent | Dario Bandiera de Gotzen S.r.l. Via Roma, 45 Olgiate Olona, IT 21057 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-26 |
| Decision Date | 2020-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760262651828 | K201382 | 000 |
| D804W12000200 | K201382 | 000 |
| D804W12000150 | K201382 | 000 |
| D804W12030200 | K201382 | 000 |
| D804W1203015FL0 | K201382 | 000 |
| D804W12030150 | K201382 | 000 |
| D804W12030100 | K201382 | 000 |
| D804W1203005FL0 | K201382 | 000 |
| D804W12030050 | K201382 | 000 |