The following data is part of a premarket notification filed by Vortech Data, Inc. with the FDA for Vortech's Personal Display System.
| Device ID | K913491 |
| 510k Number | K913491 |
| Device Name: | VORTECH'S PERSONAL DISPLAY SYSTEM |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
| Contact | Douglas L Sprague |
| Correspondent | Douglas L Sprague VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-06 |
| Decision Date | 1991-09-06 |