The following data is part of a premarket notification filed by Vortech Data, Inc. with the FDA for Vortech's Image Archival And Retrieval System.
| Device ID | K915094 |
| 510k Number | K915094 |
| Device Name: | VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
| Contact | Kem Myers |
| Correspondent | Kem Myers VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-12 |
| Decision Date | 1991-12-27 |