The following data is part of a premarket notification filed by Gendex Dental Systems with the FDA for Arthoralix 8500, Models 110-0199g1, 110-0199g2, 110-0199g3, 110-0199g4.
| Device ID | K050255 |
| 510k Number | K050255 |
| Device Name: | ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | GENDEX DENTAL SYSTEMS 901 WEST OAKTON ST. Des Plaines, IL 60018 -1884 |
| Contact | John R Miller |
| Correspondent | John R Miller GENDEX DENTAL SYSTEMS 901 WEST OAKTON ST. Des Plaines, IL 60018 -1884 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-03 |
| Decision Date | 2005-03-17 |
| Summary: | summary |