The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Cliniview.
| Device ID | K162799 |
| 510k Number | K162799 |
| Device Name: | Cliniview |
| Classification | System, Image Processing, Radiological |
| Applicant | Palodex Group Oy Nahkelantie 160 Tuusula, FI Fi-04300 |
| Contact | Jouni Karkinen |
| Correspondent | Jouni Karkinen Palodex Group Oy Nahkelantie 160 Tuusula, FI Fi-04300 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-05 |
| Decision Date | 2017-04-25 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CLINIVIEW 73712861 1504723 Dead/Cancelled |
CLINICOM, INCORPORATED 1988-02-22 |