The following data is part of a premarket notification filed by Sopro with the FDA for Sopix 2.
| Device ID | K092329 |
| 510k Number | K092329 |
| Device Name: | SOPIX 2 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati SOPRO 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 | 2009-08-04 |
| Decision Date | 2010-07-20 |
| Summary: | summary |