The following data is part of a premarket notification filed by Hightech Vision with the FDA for The Ophthimus System.
| Device ID | K896017 |
| 510k Number | K896017 |
| Device Name: | THE OPHTHIMUS SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | HIGHTECH VISION 583 MOUNTAIN AVE. North Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff HIGHTECH VISION 583 MOUNTAIN AVE. North Caldwell, NJ 07006 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-16 |
| Decision Date | 1990-10-02 |