# K083910: Vidistar Pacs & Dicom Viewer Software Server Software System, Heart View, Standalone Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Vidistar, LLC
- Decided: Apr 15, 2009 after 106 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Heartlab, Inc. Ascentia (formerly Encompass): named in the summary without a submission number
- (no number) Agfa Corp. Impax: named in the summary without a submission number
- (no number) Philips Inturis Suite: named in the summary without a submission number

## Recalls of this device
- Aug 28, 2018 · Class II · Z-2992-2018: The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study.

## Indications for use
The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. All quantitative data ranges are derived from the clinical experience of laboratories and are included in observation libraries for VidiStar users. VidiStar strongly recommends that users review these ranges with their individual diagnostic needs in mind prior to using the VidiStar PACS & DICOM Viewer Software system for clinical reporting. The VidiStar PACS & DICOM Viewer Software system should not be used for reviewing fill-field digital mammograms.

Source page: https://510kreport.com/device/K083910
Methodology: https://510kreport.com/methodology