The following data is part of a premarket notification filed by Sopro - Acteon Group with the FDA for Pspix 2 Scanner, Imaging Plate Size 0 For Pspix2 Scanner, Imaging Plate Size 1 For Pspix2 Scanner, Imaging Plate Size 2 For Pspix2 Scanner, Imaging Plate Size 3 For Pspix2 Scanner.
| Device ID | K151053 |
| 510k Number | K151053 |
| Device Name: | PSPIX 2 Scanner, Imaging Plate Size 0 For PSPIX2 Scanner, Imaging Plate Size 1 For PSPIX2 Scanner, Imaging Plate Size 2 For PSPIX2 Scanner, Imaging Plate Size 3 For PSPIX2 Scanner |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SOPRO - ACTEON GROUP ZAC ATHELIA IV AVENUE DES GENEVRIERS La Ciotat, FR 13705 |
| Contact | Philippe Boyer |
| Correspondent | Rick Rosati ACTEON, INC. 124 GAITHER DR., SUITE 140 Mount 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 | 2015-04-20 |
| Decision Date | 2015-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M430S70200111 | K151053 | 000 |
| 03760278260939 | K151053 | 000 |
| 03760278260434 | K151053 | 000 |