The following data is part of a premarket notification filed by Chicago X-ray Systems, Inc. with the FDA for Explor-x (azteh) Hf.
| Device ID | K954565 |
| 510k Number | K954565 |
| Device Name: | EXPLOR-X (AZTEH) HF |
| Classification | Unit, X-ray, Intraoral |
| Applicant | CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling, IL 60090 |
| Contact | Al Sosa |
| Correspondent | Al Sosa CHICAGO X-RAY SYSTEMS, INC. 219 MAYER AVE. Wheeling, IL 60090 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1995-10-27 |