Vortech's Image Archival and Retrieval System

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K915094 ↗

FDA Product Code

LMB

Device Class

Class I

Regulation

21 CFR Part 892.2010

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Vortech's Film Digitizer, Fd-1

  Class II

  FDA 510(k) K915362 Active Cleared 6 Apr 1992

• Vortech's Personal Display System

  Class II

  FDA 510(k) K913491 Active Cleared 6 Sep 1991

• Xpr Printer Redundancy

  Class I

  FDA 510(k) K914444 Active Cleared 27 Feb 1992

• Xlp Network Printing

  Class I

  FDA 510(k) K914191 Active Cleared 18 Feb 1992

• Vortech's Medical Imaging Gateway

  Class I

  FDA 510(k) K884434 Active Cleared 19 Jan 1989

• Vg-A Mig

  Class I

  FDA 510(k) K924229 Active Cleared 27 Nov 1992

See all devices from Vortech Data, Inc. →