# K110919: Carestream Pacs - Pathway: 510(k) (Traditional) - Applicant: Carestream Health, Inc. - Decided: Oct 20, 2011 after 202 days - Product code: LLZ (System, Image Processing, Radiological) - Device class: 2 - Regulation: 21 CFR 892.2050 - Recalls of this device: 50 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K954678 (1996). 8 ancestors in all. 8 later devices descend from it; 2 cite it directly. 0 of 17 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K083673: Carestream Pacs, Model Carestream Pacs Vii, Carestream Health, Inc. (2008) Summary page 1. ## Most influential descendants - K132824: Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application (2014), 6 descendants of its own - K151774: CARESTREAM Vue Motion (2015), 4 descendants of its own - K170434: Enterprise Imaging XERO Viewer 8.1 (2017), 3 descendants of its own - K200822: Braid (2020), 1 descendant of its own - K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own ## 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, - Sep 16, 2013 · Class II · Z-0248-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0229-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0255-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0250-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0228-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0243-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0214-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0216-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0218-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0222-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0240-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0224-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0259-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0211-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0236-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0238-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0251-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0235-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0257-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0258-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0220-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0237-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0217-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0223-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0225-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0239-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0221-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0242-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0246-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0252-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0226-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0215-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0232-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0230-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0233-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0241-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0212-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0249-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0244-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0253-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0219-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0256-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0254-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0231-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0213-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0227-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0245-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0260-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into - Sep 16, 2013 · Class II · Z-0234-2014: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into ## Indications for use The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable 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 (31D) images. It is a single system that integrates the review, dictation and reporting tools that creates a productive work environment for the radiologists and physicians. The CARESTREAM PACS Lightweight Viewer software program is used for patient management by the referral community in order to access and display patient data, medical reports, and medical images from different modalities including CR, DR, CT, MR, NM and US after the primary reading has been completed on dedicated diagnostic workstations, The CARESTREAM PACS Lightweight Viewer provides wireless and portable access to medical images for referral purposes. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography. Source page: https://510kreport.com/device/K110919 Methodology: https://510kreport.com/methodology