The following data is part of a premarket notification filed by Panoramic Corp. with the FDA for Encompass Hf100- Eagle Panoramic/cephalometric X-ray.
| Device ID | K110371 |
| 510k Number | K110371 |
| Device Name: | ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | PANORAMIC CORP. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-08 |
| Decision Date | 2011-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862309000354 | K110371 | 000 |