# K120851: Communify Pacs Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Communify Health, LLC
- Decided: Feb 19, 2013 after 335 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: 8 generations back to K954874 (1996). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110797: Communify Pacs Viewer, Flying Squirrel Storage, LLC (2011) Summary page 1.
- K071964: Mim 4.1 (Seastar), Mimvista Corp. (2007) Summary page 1.

## Indications for use
The Communify PACS Viewer 1.5 is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media CDICOM), DICOM-RT and non-DICOM information and data. The Communify PACS Viewer 1.5 is a software application that runs on standard "off-the-sheir" personal computers, business computers, and servers running standard operating systems. Communify PACS Viewer is an image and display software that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulations, create graphical representations of anatomical areas, and perform quantitative measurements. Communify PACS Viewer 1.5 is designed to support the use and viewing of DICOM-RT (radiotherapy extensions), such as Structure Set, Contour, Dose, Dose Value Histogram and Plan information. In Communify PACS Viewer 1.5, mammographic images should only be viewed on mammography monitors that are cleared or approved by FDA. Users should not apply lossy compression to mammographic images and only DICOM "for presentation" mammography images may be displayed. Communify PACS Viewer 1.5 does not manipulate or edit any mammography image acquisition system manufacturer's proprietary image processing methods. Please note that Communify PACS Viewer 1.5 does not run on mobile smartphones and tablets.

Source page: https://510kreport.com/device/K120851
Methodology: https://510kreport.com/methodology