The following data is part of a premarket notification filed by De Gotzen S.r.l with the FDA for Acteon Imaging Suite.
| Device ID | K192165 |
| 510k Number | K192165 |
| Device Name: | Acteon Imaging Suite |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2020-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D804W09000460 | K192165 | 000 |
| D8049902630 | K192165 | 000 |