The following data is part of a premarket notification filed by Panoramic Corp. with the FDA for Model Pc-1000 Panoramic/cephalometric X-ray Systems.
| Device ID | K043557 |
| 510k Number | K043557 |
| Device Name: | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PANORAMIC CORP. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm PANORAMIC CORP. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862309000347 | K043557 | 000 |
| 00862309000330 | K043557 | 000 |