The following data is part of a premarket notification filed by De Gotzen S.r.l. with the FDA for X-mind Trium.
| Device ID | K160166 |
| 510k Number | K160166 |
| Device Name: | X-MIND Trium |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | DE GOTZEN S.R.L. VIA ROMA, 45 Olgiate Olona,, IT 21057 |
| Contact | Olivier Balouka |
| Correspondent | Olivier Balouka 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 | 2016-01-27 |
| Decision Date | 2016-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D804W12000070 | K160166 | 000 |
| D804W09002260 | K160166 | 000 |
| D804W09002250 | K160166 | 000 |
| D804W09000560 | K160166 | 000 |
| D804W09000550 | K160166 | 000 |
| D804W09000120 | K160166 | 000 |
| D804W09000110 | K160166 | 000 |
| D804W09000100 | K160166 | 000 |
| D804W09000090 | K160166 | 000 |
| D804W09000080 | K160166 | 000 |
| D804W09000070 | K160166 | 000 |
| D804W09000060 | K160166 | 000 |
| D804W09000050 | K160166 | 000 |
| D804W09000040 | K160166 | 000 |
| D804W09000030 | K160166 | 000 |
| D804W09000020 | K160166 | 000 |
| D804W09002300 | K160166 | 000 |
| D804W09002310 | K160166 | 000 |
| D804W12000050 | K160166 | 000 |
| D804W12000030 | K160166 | 000 |
| D804W12000010 | K160166 | 000 |
| D804W13050040 | K160166 | 000 |
| D804W13050030 | K160166 | 000 |
| D804W13050020 | K160166 | 000 |
| D804W13050010 | K160166 | 000 |
| D804W13000040 | K160166 | 000 |
| D804W13000030 | K160166 | 000 |
| D804W13000020 | K160166 | 000 |
| D804W13000010 | K160166 | 000 |
| D804W09002400 | K160166 | 000 |
| D804W09002390 | K160166 | 000 |
| D804W09002330 | K160166 | 000 |
| D804W09002320 | K160166 | 000 |
| D804W09000010 | K160166 | 000 |