The following data is part of a premarket notification filed by Sopro - Acteon Group with the FDA for Sopix Inside, Sopix2 Inside.
| Device ID | K140013 |
| 510k Number | K140013 |
| Device Name: | SOPIX INSIDE, SOPIX2 INSIDE |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SOPRO - ACTEON GROUP 124 GAITHER DRIVE SUITE #140 Mt. Laurel, NJ 08055 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SOPRO - ACTEON GROUP 124 GAITHER DRIVE SUITE #140 Mt. Laurel, NJ 08055 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-02 |
| Decision Date | 2014-09-05 |