# K153103: CARESTREAM Vue PACS

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Feb 12, 2016 after 109 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
Longest line of descent: 11 generations back to K896095 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120196: Olea Sphere, Olea Medical (2012) Summary page 5.
- K132095: Olea Sphere, Olea Medical (2013) Summary page 5.
- K973835: Philips Easyvision Workstation, Philips Medical Systems, Inc. (1998) Summary page 5.

## Recalls of this device
- Oct 10, 2024 · Class II · Z-0497-2025: A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, 

## 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 contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D), CT Perfusion (CTP), and Digital Subtraction Angiography (DSA) 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 ease the process of analyzing and comparing Computed Tomography Perfusion (CTP) images of adult patients. The Arterial Input Function (AIF), Venous Output Function (VOF), and Brain Centerline are automatically detected with the ability for manual correction by the user. Blood perfusion parameters are automatically calculated and displayed as a set of user friendly perfusion maps and perfusion tables summarizing the results. The perfusion maps include relative Cerebral Blood Volume (rCBV), relative Cerebral Blood Flow (rCBF), Mean Transit Time (MTT), Time to Peak (TTP), and Time to maximum impulse response function (TMAX). The perfusion tables include the calculation of parameters related to tissue flow (perfusion) and tissue blood volume. 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. The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.

Source page: https://510kreport.com/device/K153103
Methodology: https://510kreport.com/methodology