The following data is part of a premarket notification filed by Sopro - Acteon Group with the FDA for Sopix.
| Device ID | K142995 |
| 510k Number | K142995 |
| Device Name: | SOPIX |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SOPRO - ACTEON GROUP Laciotat, FR 13705 |
| Contact | Philippe Boyer |
| Correspondent | Rick Rosati SATELEC-ACTEON GROUP 124 GAITHER DRIVE , SUITE 140 Mt Laurel, NJ 08054 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2015-08-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SOPIX 79012709 3051241 Live/Registered |
SOPRO (SA) 2005-01-28 |