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Vitrea View

FDA UDI

Class II (US FDA UDI)

by Canon Medical Informatics, Inc.

Identity

Trade Name
Vitrea View FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care. Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the web-based zero-footprint nature of the Vitrea View software. The Vitrea View software offers scalability to add new users as demand grows, may be deployed in a virtualized environment. FDA UDI
Model / Reference
7.1.3 FDA UDI
Description
Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software enables clinicians and other medical professionals to access patients’ medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care. Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the web-based zero-footprint nature of the Vitrea View software. The Vitrea View software offers scalability to add new users as demand grows, may be deployed in a virtualized environment. FDA UDI

Identifiers

Primary DI / UDI-DI
00853866003346 FDA UDI
510(k) Number
K163232 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological PACS software

Vitrea View by Canon Medical Informatics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological PACS software.

Cleared under the same submission

K163232 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Canon Medical Informatics, Inc.

Sources (1)

  • FDA UDI bd615822-aa43-432b-be55-bd0ffa4b4250 34 fields · synced Jun 9, 2026