# K253927: LiveMedica Enterprise PACS

- Pathway: 510(k) (Traditional)
- Applicant: Live Medica, LLC
- Decided: Feb 6, 2026 after 60 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: 6 generations back to K945188 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082269: Visage Pacs, Version 6.0/CS 3.1, Visage Imaging, Inc. (2008) Summary page 5.

## Indications for use
LiveMedica Enterprise PACS is a system for distributing, viewing, processing and archiving medical images within and outside healthcare environments. The LiveMedica Enterprise PACS server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The supported modalities are listed in the DICOM Conformance Statement. LiveMedica Enterprise PACS is to be used only by trained and instructed health care professionals. It can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnosis, however, resides with the doctor and/or their medical staff in their own area of responsibility. Although the web and technologies allow the software to run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws. Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K253927
Methodology: https://510kreport.com/methodology