The following data is part of a premarket notification filed by Owandy with the FDA for I-max Touch 3d.
| Device ID | K130443 |
| 510k Number | K130443 |
| Device Name: | I-MAX TOUCH 3D |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | OWANDY 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin OWANDY 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-06-14 |
| Summary: | summary |