# K183013: Vitrea Software Package, VSTP-001A - Pathway: 510(k) (Special) - Applicant: Canon Medical Systems Corporation - Decided: Nov 26, 2018 after 26 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: 14 generations back to K913770 (1991). 177 ancestors in all. 9 later devices descend from it; 1 cites it directly. 0 of 187 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K151091: Vitrea Software Toshiba Package, VSTP-001A, Toshibamedical Systems Corporation (2015). Our reading of the summary gave K151093, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “VSTP-001A”. - K171222: Vitrea Software Toshiba Package; VSTP-001A, Toshibamedical Systems Corporation (2017) Summary page 5. - K173088: Vitrea Software Toshiba Package VSTP-001A, Toshibamedical Systems Corporation (2018) Summary page 5. - K180323: Vitrea Software Package; VSTP-001A, Canon Medical Systems Corporation (2018) Summary page 6. ## Most influential descendants - K192923: Vitrea Software Package (2020), 8 descendants of its own - K203312: Vitrea Software Package, VSTP-001A (2021), 7 descendants of its own - K213504: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (2022), 6 descendants of its own - K232835: Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System (2024), 3 descendants of its own - K242403: Aquilion ONE (TSX-308A/3) V1.5 (2024), 2 descendants of its own ## Indications for use Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchanges of multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following indications: The CT/XA Cerebral Artery Morphological Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio. The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease. The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries. The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images. The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement. The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application. The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis. Embolization Plan is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver. The DE Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3mm with Dual Energy CT studies. The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies. Source page: https://510kreport.com/device/K183013 Methodology: https://510kreport.com/methodology