The following data is part of a premarket notification filed by De Götzen S.r.l. with the FDA for X-mind Prime (under Trade Mark Acteon), I-max (under Trade Mark Owandy Radiology).
| Device ID | K203374 |
| 510k Number | K203374 |
| Device Name: | X-MIND Prime (under Trade Mark Acteon), I-MAX (under Trade Mark Owandy Radiology) |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | de Götzen S.r.l. Via Roma, 45 Olgiate Olona, IT 21057 |
| Contact | Dario Bandiera |
| Correspondent | Dario Bandiera de Götzen S.r.l. Via Roma, 45 Olgiate Olona, IT 21057 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D804W12000090 | K203374 | 000 |
| D804W1200001FL0 | K203374 | 000 |
| D804W12030010 | K203374 | 000 |
| D804W1203001FL0 | K203374 | 000 |
| D804W12030090 | K203374 | 000 |
| D804W1203009DS0 | K203374 | 000 |
| 03760262651620 | K203374 | 000 |
| 03760262651637 | K203374 | 000 |
| D804W1200009DS0 | K203374 | 000 |
| 03760262651606 | K203374 | 000 |