# K012327: Csist Dicom Gateway/Image Manager

- Pathway: 510(k) (Traditional)
- Applicant: Csist
- Decided: Dec 20, 2001 after 150 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922164 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software, Olicon Imaging Systems, Inc. (1997) Summary page 1.
- K003762: Ali 3D Tool Module for Medical Images, A.L.I. Technologies, Inc. (2001) Summary page 1.

## Most influential descendants
- K092581: Mits Dicom Gateway and Image Manager (2009), 0 descendants of its own

## Indications for use
The CSIST DICOM Gateway and Image Manager™ is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources (i.e. ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K012327
Methodology: https://510kreport.com/methodology