The following data is part of a premarket notification filed by Vortech Data, Inc. with the FDA for Vortech's Medical Imaging Gateway.
| Device ID | K884434 |
| 510k Number | K884434 |
| Device Name: | VORTECH'S MEDICAL IMAGING GATEWAY |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | VORTECH DATA, INC. 1891 PRESTON WHITE DRIVE, SUITE 200 Reston, VA 22091 |
| Contact | Gitlin, Dph |
| Correspondent | Gitlin, Dph VORTECH DATA, INC. 1891 PRESTON WHITE DRIVE, SUITE 200 Reston, VA 22091 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-20 |
| Decision Date | 1989-01-19 |