Canon Medical Informatics, Inc.
Minnetonka, MN, US
CANON MEDICAL INFORMATICS, INC. appears in FDA device records in Minnetonka, MN. FDA records list 46 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Canon Medical Informatics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Vital Images, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 46 510(k) clearances for Canon Medical Informatics, Inc. between 1995 and 2026. The busiest year on record is 2015, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 6 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | QIH | Substantially Equivalent | |
| K252217 | CT VScore+ | JAK | Substantially Equivalent | |
| K243240 | Vitrea CT VScore | JAK | Substantially Equivalent | |
| K223261 | Open Rib | JAK | Substantially Equivalent | |
| K222662 | Vitrea CT Cardiac Analysis | LLZ | Substantially Equivalent | |
| K181247 | Vitrea CT Brain Perfusion | LLZ | Substantially Equivalent | |
| K182230 | Multi Modality Viewer | LLZ | Substantially Equivalent | |
| K172855 | Vitrea Advanced Visualization, Version 7.6 | LLZ | Substantially Equivalent | |
| K163232 | Vitrea View | LLZ | Substantially Equivalent | |
| K163574 | Multi Modality Viewer | LLZ | Substantially Equivalent | |
| K161157 | Vitrea CT Dual Energy Image View | JAK | Substantially Equivalent | |
| K161419 | Multi Modality Viewer | LLZ | Substantially Equivalent | |
| K160150 | Vitrea CT Colon Analysis | LLZ | Substantially Equivalent | |
| K151283 | Lung Analysis Software | JAK | Substantially Equivalent | |
| K151919 | Vitrea CT Lung Density Analysis Software | JAK | Substantially Equivalent | |
| K151115 | MR Core Software | LLZ | Substantially Equivalent | |
| K150104 | Vitrea CT Myocardial Perfusion | JAK | Substantially Equivalent | |
| K150738 | VitreaView | LLZ | Substantially Equivalent | |
| K150258 | Vitrea, Version 7.0 Medical Image Processing Software | LLZ | Substantially Equivalent | |
| K143079 | Endovascular Stent Planning Software | LLZ | Substantially Equivalent | |
| K141302 | VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) | LLZ | Substantially Equivalent | |
| K140395 | VITREA IMAGE DENOISING SOFTWARE | LLZ | Substantially Equivalent | |
| K122578 | VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING | LLZ | Substantially Equivalent | |
| K121213 | VITREAADVANCED | LLZ | Substantially Equivalent | |
| K122136 | VITREAVIEW | LLZ | Substantially Equivalent | |
| K112531 | VITREA CT MYOCARDIAL ANALYSIS | LLZ | Substantially Equivalent | |
| K111892 | VITREAVIEW SOFTWARE 6.1 | LLZ | Substantially Equivalent | |
| K091498 | VITREA ENDOVASCULAR STENT PLANNING SOFTWARE | LLZ | Substantially Equivalent | |
| K072821 | VITREA 4DCT | LLZ | Substantially Equivalent | |
| K071362 | VITAL CONNECT 4.1 | LLZ | Substantially Equivalent | |
| K071331 | VITREA VERSION 4.0 | LLZ | Substantially Equivalent | |
| K062328 | VITREAACCESS, VERSION 1.0 | LLZ | Substantially Equivalent | |
| K062154 | VITAL CONNECT 4.0 | LLZ | Substantially Equivalent | |
| K061624 | VITREA, VERSION 3.9 | LLZ | Substantially Equivalent | |
| K060378 | VITREA2 VERSION 3.8.1 | LLZ | Substantially Equivalent | |
| K052632 | VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE | LLZ | Substantially Equivalent | |
| K043333 | VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM | LLZ | Substantially Equivalent | |
| K040876 | ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE | LLZ | Substantially Equivalent | |
| K040305 | VITREA2 VERSION 3.5 | LLZ | Substantially Equivalent | |
| K032748 | VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE | LLZ | Substantially Equivalent | |
| K003639 | VITREA 2 CT PERFUSION OPTION | JAK | Substantially Equivalent | |
| K003230 | V SCORE WITH AUTO GATE MODEL TBD | JAK | Substantially Equivalent | |
| K002519 | VITREA 2, VERSION 2.1 | LLZ | Substantially Equivalent | |
| K001682 | VSCORE WITH EKG SIGNAL GATING | JAK | Substantially Equivalent | |
| K990442 | ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3 | LLZ | Substantially Equivalent | |
| K953259 | VOXELVIEW | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2134213 | 3001654007 | CANON MEDICAL INFORMATICS, INC. | 5850 Opus Parkway Suite 300, MINNETONKA, MN 55343 US | 2026 | |
| 3006619220 | 3006619220 | Canon Medical Informatics A/S | Krumtappen 4, Etage 3, Valby Hovedstaden DK-2500 DK | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QIHAutomated Radiological Image Processing Software
- IYLCollimator, Dermatological, Therapeutic X-Ray
- DQKComputer, Diagnostic, Programmable
- OEBLung Computed Tomography System, Computer-Aided Detection
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPSSystem, Tomography, Computed, Emission
- JAKSystem, X-Ray, Tomography, Computed
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0169-2014 | VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography. | Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. | Class II | Terminated | |
| Z-1181-2013 | Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion. | Vital Images, Inc. (Vital Images) received one report about potential user confusion when viewing a brain perfusion scan on Vitrea CT Brain Perfusion 2D when the scan was performed using a wide coverage shuttle acquisition technique. This may result in patient treatment delays, misdiagnosis or mistreatment. | Class II | Terminated | |
| Z-1144-2013 | Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides a variety of tools for working with clinical CT images of the coronary arteries, heart, and surrounding tissue. | Vital Images has made a decision to perform a field correction to the Vitrea CT Multi-Chamber Cardiac Functional Analysis application. Vital Images has identified a defect in which numerical values may be incorrect in the Results Table under the Cardiac Analysis portion of the user interface. | Class II | Terminated | |
| Z-1002-2013 | Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, D, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. | Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3. This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia | Class II | Terminated | |
| Z-0186-2013 | Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring. | Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions. | Class II | Terminated | |
| Z-0388-2012 | Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices. | Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions. | Terminated | ||
| Z-0797-2011 | Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the infection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances. | Vital Images Inc., reported that a software defect exists with Vitrea fX 2.1, 3.0 and 3.1 CT Brain Analysis whereby the annotated numeric ROI values on a batched perfusion map are incorrect when created using the auto batching function (from the right click menu) with the auto ROI templates enabled. | Terminated | ||
| Z-1021-2011 | Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. | There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data | Terminated | ||
| Z-1600-2010 | Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. | Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0 or Vitre Enterprise Suite 1.2. because incorrect measurements may result. Questions or comments are directed to the firm's Customer Support at [email protected] or at 1-800-208-3005. | Terminated | ||
| Z-0520-2008 | Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images) | Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the region. If the user then changes the slice shown by scrolling through additional slices, the original SUV measurements will remain on the screen and do not up | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain