FDA.reportPublic FDA data

Canon Medical Informatics A/S

Matched from indexed company URL: Canon Medical Informatics A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066192203006619220Canon Medical Informatics A/S1N2026-01-01Krumtappen 4, Etage 3 Valby Hovedstaden DK DK-2500

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
256231736055323K051809EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEMLLZ2005-08-15
256231139822940

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ12005-08-15

GUDID#

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2026-04-03

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2025-11-21

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2025-01-10

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2025-08-15

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2025-04-04

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2025-01-10

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2024-05-22

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2024-04-03

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2024-01-19

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2024-01-19

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2023-11-28

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2023-11-08

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2023-09-18

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2023-09-21

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2023-09-18

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2023-03-06

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2022-11-04

Vitrea Read - Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions.

Canon Medical Informatics A/S

2022-04-22