The following data is part of a premarket notification filed by Panoramic Corp. with the FDA for Encompass Eagle 3d Cbct/panoramic/cephalometric Dental X-ray.
| Device ID | K152489 |
| 510k Number | K152489 |
| Device Name: | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PANORAMIC CORP. 4321 Goshen Rd Ft. Wayne, IN 46818 |
| Contact | Doug Pack |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-01 |
| Decision Date | 2016-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862309000378 | K152489 | 000 |