The following data is part of a premarket notification filed by Vortech Data, Inc. with the FDA for Vortech's Autorouter (automatic Image Routing).
Device ID | K925097 |
510k Number | K925097 |
Device Name: | VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING) |
Classification | System, Digital Image Communications, 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 | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-08 |
Decision Date | 1993-01-15 |