# K170580: Carestream Vue PACS

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Apr 11, 2017 after 42 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: 12 generations back to K971684 (1997). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152602: Olea Sphere V3.0, Olea Medical (2016) Summary page 4.

## Most influential descendants
- K201948: AcroDTI Visualizer (2020), 0 descendants of its own

## Indications for use
“The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system is to be used by trained professionals including, but not limited to, physicians and medical technicians. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. The system contains a Perfusion module with interactive tools to analyze and compare Computed Tomography Perfusion (CTP) and MR Perfusion (MRP) images of adult patients. Blood perfusion parameters are automatically calculated and displayed as a set of perfusion maps and perfusion tables. The perfusion tables include the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. The system contains a Diffusion Module with interactive tools to ease the process of analyzing and comparing MR Diffusion Weighted images (DWI) and MR Diffusion Tensor Imaging (DTI) of adult patients. This module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The system supports Subtraction with interactive tools to aid with the analysis of Digital Subtraction Angiography (DSA) images in both interventional radiology and cardiology. Subtraction automatically subtracts a mask from contrast frames of an X-Ray Angiography study for visualization of vascular anatomy and pathology of adult patients.”

Source page: https://510kreport.com/device/K170580
Methodology: https://510kreport.com/methodology