Data / Medical devices / United States / Canon Medical Informatics, Inc.
Canon Medical Informatics, Inc.: FDA-registered device maker in Minnetonka, MN, United States, 64 510(k) clearances
Canon Medical Informatics, Inc. is registered with the FDA (registration 2134213) in Minnetonka, MN, United States. It lists 10 device types. The FDA files 64 510(k) clearances under its listings, the newest dated May 22, 2026. 10 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2134213
- FEI number
- 3001654007
- Address
- 5850 Opus Parkway Suite 300, Minnetonka, MN, United States, 55343
- Owner or operator
- CANON MEDICAL INFORMATICS, INC. (9024582)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- November 19, 2007
- Registered through
- 2027
- Brand names listed
- CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE, CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE, CT Body Perfusion 4D for fX, CT Brain Analysis 4D, CT Brain Perfusion, CT Cardiac Analysis, CT Cardiac Functional Analysis, CT Colon Analysis and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Collimator, Dermatological, Therapeutic X-Ray | IYL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lung Computed Tomography System, Computer-Aided Detection | OEB | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2026 | K260324 | Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning | QIH | Substantially Equivalent | Canon Medical Informatics, Inc. | accessdata.fda.gov |
| November 28, 2025 | K252217 | CT VScore+ | JAK | Substantially Equivalent | Canon Medical Informatics, Inc. | accessdata.fda.gov |
| April 10, 2025 | K243240 | Vitrea CT VScore | JAK | Substantially Equivalent | Canon Medical Informatics, Inc. | accessdata.fda.gov |
| July 13, 2023 | K223261 | Open Rib | JAK | Substantially Equivalent | Canon Medical Informatics, Inc. | accessdata.fda.gov |
| October 14, 2022 | K222662 | Vitrea CT Cardiac Analysis | LLZ | Substantially Equivalent | Canon Medical Informatics, Inc. | accessdata.fda.gov |
| November 20, 2018 | K181247 | Vitrea CT Brain Perfusion | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| September 7, 2018 | K182230 | Multi Modality Viewer | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| March 30, 2018 | K180323 | Vitrea Software Package; VSTP-001A | LLZ | Substantially Equivalent | Canon Medical Systems Corporation | accessdata.fda.gov |
| January 31, 2018 | K173088 | Vitrea Software Toshiba Package VSTP-001A | LLZ | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| October 5, 2017 | K172855 | Vitrea Advanced Visualization, Version 7.6 | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| July 21, 2017 | K163232 | Vitrea View | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| June 8, 2017 | K171222 | Vitrea Software Toshiba Package; VSTP-001A | LLZ | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| January 26, 2017 | K163574 | Multi Modality Viewer | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| November 3, 2016 | K161157 | Vitrea CT Dual Energy Image View | JAK | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| July 13, 2016 | K161419 | Multi Modality Viewer | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| March 16, 2016 | K160150 | Vitrea CT Colon Analysis | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| March 3, 2016 | K152602 | Olea Sphere V3.0 | LLZ | Substantially Equivalent | Olea Medical | accessdata.fda.gov |
| October 30, 2015 | K151283 | Lung Analysis Software | JAK | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| October 10, 2015 | K151919 | Vitrea CT Lung Density Analysis Software | JAK | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| July 13, 2015 | K151091 | Vitrea Software Toshiba Package, VSTP-001A | LLZ | Substantially Equivalent | Toshibamedical Systems Corporation | accessdata.fda.gov |
| June 3, 2015 | K151115 | MR Core Software | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| April 17, 2015 | K150104 | Vitrea CT Myocardial Perfusion | JAK | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| April 6, 2015 | K150738 | VitreaView | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| March 5, 2015 | K150258 | Vitrea, Version 7.0 Medical Image Processing Software | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| February 13, 2015 | K150122 | TOMTEC-ARENA TTA2 | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| January 6, 2015 | K140587 | MR-CT VVA | LLZ | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
| December 4, 2014 | K143079 | Endovascular Stent Planning Software | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| August 1, 2014 | K141302 | VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| July 22, 2014 | K141652 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | KPS | Substantially Equivalent | Cedars-Sinai Medical Center | accessdata.fda.gov |
| May 13, 2014 | K140395 | VITREA IMAGE DENOISING SOFTWARE | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| March 20, 2013 | K130393 | MIRADA RTX | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| February 26, 2013 | K123433 | CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE | KPS | Substantially Equivalent | Cedars-Sinai Medical Center | accessdata.fda.gov |
| February 25, 2013 | K122578 | VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| November 2, 2012 | K121213 | VITREAADVANCED | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| April 19, 2012 | K120196 | OLEA SPHERE | LLZ | Substantially Equivalent | Olea Medical | accessdata.fda.gov |
| April 13, 2012 | K120135 | 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| December 30, 2011 | K113337 | VISIA DYNAMIC REVIEW | LNH | Substantially Equivalent | MeVis Medical Solutions AG | accessdata.fda.gov |
| September 23, 2011 | K112474 | CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE | KPS | Substantially Equivalent | Cedars-Sinai Medical Center | accessdata.fda.gov |
| May 24, 2011 | K110746 | 4D LV-ANALYSIS 3.0 | DQK | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| April 8, 2011 | K110667 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| April 7, 2011 | K110595 | 4D SONO-SCAN 1.0 | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| April 1, 2011 | K100714 | CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 | KPS | Substantially Equivalent | Cedars-Sinai Medical Center | accessdata.fda.gov |
| January 27, 2011 | K103782 | 4D MV-ASSESSMENT 2.0 | DQK | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| October 4, 2010 | K102687 | MIRADA RT | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| August 4, 2010 | K101279 | CORRIDOR4DM V2010 MODEL: V2010 | LLZ | Substantially Equivalent | Invia | accessdata.fda.gov |
| August 4, 2010 | K091529 | ICAD VERALOOK CTC CAD SOFTWARE | JAK | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| June 23, 2010 | K101228 | MIRADA XD | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| November 6, 2009 | K092954 | CADSTREAM VERSION 5 | LLZ | Substantially Equivalent | Confirma, Inc. | accessdata.fda.gov |
| July 20, 2009 | K091444 | PERFSCAPE | LNH | Substantially Equivalent | Olea Medical | accessdata.fda.gov |
| May 22, 2009 | K090461 | IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| February 19, 2009 | K083491 | NEUROSCAPE | LLZ | Substantially Equivalent | Olea Medical | accessdata.fda.gov |
| March 4, 2008 | K073156 | QPLAQUE MR | LNH | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
| February 20, 2008 | K072821 | VITREA 4DCT | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| January 9, 2008 | K073169 | SCIMAGE PICOMENTERPRISE | LLZ | Substantially Equivalent | Scimage, Inc. | accessdata.fda.gov |
| December 21, 2007 | K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM | OEB | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| June 20, 2007 | K071232 | IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS | LLZ | Substantially Equivalent | Tomtec Imaging Systems GmbH | accessdata.fda.gov |
| May 30, 2007 | K071362 | VITAL CONNECT 4.1 | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| May 25, 2007 | K071331 | VITREA VERSION 4.0 | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| December 15, 2005 | K052632 | VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| December 15, 2004 | K043333 | VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| February 24, 2004 | K040305 | VITREA2 VERSION 3.5 | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| October 29, 2003 | K032748 | VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE | LLZ | Substantially Equivalent | Vital Images, Inc. | accessdata.fda.gov |
| August 30, 2000 | K994283 | MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM | LNH | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
| March 2, 2000 | K994282 | MRI- FLOW ANALYTICAL SOFTWARE PACKAGE | LNH | Substantially Equivalent | Medis Medical Imaging Systems BV | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 21, 2013 | 66659 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| March 15, 2013 | 64833 | Class II | Terminated | 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 brai | 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. | accessdata.fda.gov |
| March 15, 2013 | 64683 | Class II | Terminated | 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 Ent | 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. | accessdata.fda.gov |
| February 5, 2013 | 64461 | Class II | Terminated | 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, | 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 degr | accessdata.fda.gov |
| August 13, 2012 | 63104 | Class II | Terminated | 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 Vitre | 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 t | accessdata.fda.gov |
| November 11, 2011 | 60418 | Not yet classified | Terminated | 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 t | 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. | accessdata.fda.gov |
| October 14, 2010 | 57219 | Not yet classified | Terminated | 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 | 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. | accessdata.fda.gov |
| August 23, 2010 | 56923 | Not yet classified | Terminated | 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 imagin | 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 | accessdata.fda.gov |
| February 23, 2010 | 55222 | Not yet classified | Terminated | 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 or at. | accessdata.fda.gov |
| November 8, 2007 | 45820 | Not yet classified | Terminated | 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 | 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 w | accessdata.fda.gov |
Compare with other makers
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- All makers of Lung Computed Tomography System, Computer-Aided Detection
- All makers of System, Nuclear Magnetic Resonance Imaging
Updated May 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.