# K061372: Centricity AW Suite Option - Pathway: 510(k) (Traditional) - Applicant: Ge Healthcare Information Technologies - Decided: May 30, 2006 after 13 days - Product code: LLZ (System, Image Processing, Radiological) - Device class: 2 - Regulation: 21 CFR 892.2050 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 6 generations back to K913770 (1991). 35 ancestors in all. No later device cites it as a predicate yet. 0 of 36 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1. - K993792: Smart Vessel Analysis (Smart VA) Option, Ge Medical Systems, Inc. (1999) Summary page 1. - K042694: Advanced Lung Analysis II, GE Medical Systems (2004) Summary page 1. - K031871: Autobone, Ge Medical Systems Europe (2003) Summary page 1. - K041267: Cardiq Analysis Iii, General Electric Medical Systems (2004) Summary page 1. - K041270: CT Colonography II, General Electric Medical Systems (2004) Summary page 1. - K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 1. ## Recalls of this device - Jun 11, 2008 · Not classified · Z-2183-2008: When using any vessel analysis protocol of the AW Suite Card IQ application, the software can reload saved tracking objects (Save State) incorrectly and display an incorrect vessel label over the rest - May 9, 2008 · Not classified · Z-1825-2008: Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or ## Indications for use Centricity AW Suite is an optional software package that provides an interface between the Centricity PACS Workstation and Volume Viewer such that both applications con run on a single platform while maintaining common patient & exam context. Optional advanced analysis extensions of the Volume Viewer application include: AutoBone, Advanced Vessel Analysis, CT Colonography, CardlQ Analysis, and Advanced Lung Analysis. Volume Viewer allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio, NM and PET Scanning devices. The combination of acquired images. reconstructed images. annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning. Advanced Vessel Analysis can be used in the analysis of 3D angiography data. Itprovides a number of display, measurement and batch archive features and will aid physicians in studying user-selected vessels for stenosis analysis. pre/post stent planning and directional vessel tortuosity visualization. CardlQ Analysis allows the visualization of 2D and 30 medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 2D/30 rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process. render, review, archive and visualize cardiac anatomy and coronary vessels. CT Colonography allows the visualization of 20 and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses. cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 20. 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists. Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies. AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. Advanced Lung Analysis is intended to provide on optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol. thus providing an estimation of the volume doubling time. ALA software allows analysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S)and cylindrical (C)anatomical regions. such as nodules, cysts. scars, and vessels Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques. Source page: https://510kreport.com/device/K061372 Methodology: https://510kreport.com/methodology