The following data is part of a premarket notification filed by Dolphin Imaging Systems with the FDA for Digigraph Diagnostic Work/station.
| Device ID | K896099 |
| 510k Number | K896099 |
| Device Name: | DIGIGRAPH DIAGNOSTIC WORK/STATION |
| Classification | Cephalometer |
| Applicant | DOLPHIN IMAGING SYSTEMS 24841 AVENUE TIBBETTS Valencia, CA 91355 |
| Contact | Tom Hazen |
| Correspondent | Tom Hazen DOLPHIN IMAGING SYSTEMS 24841 AVENUE TIBBETTS Valencia, CA 91355 |
| Product Code | EAG |
| CFR Regulation Number | 872.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-20 |
| Decision Date | 1991-01-31 |