The following data is part of a premarket notification filed by Fair Image, Inc. with the FDA for Dexis Model 601 Dental Electronic Imaging System.
| Device ID | K962631 |
| 510k Number | K962631 |
| Device Name: | DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | FAIR IMAGE, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf FAIR IMAGE, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-05 |
| Decision Date | 1996-11-26 |