# K140797: Ipacs Medical Image Management System

- Pathway: 510(k) (Traditional)
- Applicant: Visbion Limited
- Decided: Dec 12, 2014 after 256 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 4.

## Indications for use
IPACS Medical Image Management Software is used for viewing medical images. IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records. IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in pre-operative planning and annotations and measurements to aid in diagnosis. Typical users of IPACS Medical Image Management Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.

Source page: https://510kreport.com/device/K140797
Methodology: https://510kreport.com/methodology