# K041326: Medcommons Open Radiology Gateway

- Pathway: 510(k) (Abbreviated)
- Applicant: Medcommons, Inc.
- Decided: Jul 27, 2004 after 70 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: 5 generations back to K896095 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.
- K012211: Efilm Workstation, Efilm Medical, Inc. (2001) Summary page 1.

## Indications for use
MedCommons Open RadiologyTM Gateway (MedCommons Gateway ) is a software application for viewing medical images. Typical MedCommons Gateway TM users are healthcare professionals, such as, clinicians, radiologists, and technologists. MedCommons GatewayT M receives, communicates, and displays digital images and data from various types of imaging and image processing system, such CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways and image processing sources). MedCommons GatewayTM can be integrated with an institution's HIS or RIS, linking or transferring images and data into electronic patient records.

Source page: https://510kreport.com/device/K041326
Methodology: https://510kreport.com/methodology