The following data is part of a premarket notification filed by Imaging Sciences International with the FDA for Cone Beam 3d And 2d Panoramic Dental Imaging System.
| Device ID | K133620 |
| 510k Number | K133620 |
| Device Name: | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | IMAGING SCIENCES INTERNATIONAL 1910 NORTH PENN RD. Hatfield, PA 19454 |
| Contact | Ruth Pui |
| Correspondent | Ruth Pui IMAGING SCIENCES INTERNATIONAL 1910 NORTH PENN RD. Hatfield, PA 19454 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-25 |
| Decision Date | 2014-05-14 |
| Summary: | summary |