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Vitrea

FDA UDI

Class II (US FDA UDI)

by Canon Medical Informatics, Inc.

Identity

Trade Name
Vitrea FDA UDI
Generic Name
Radiological PACS software FDA UDI
Device Name
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician. FDA UDI
Model / Reference
6.9 FDA UDI
Description
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician. FDA UDI

Identifiers

Primary DI / UDI-DI
00853866003179 FDA UDI
510(k) Number
K032748 FDA UDI
K040305 FDA UDI
K043333 FDA UDI
K052632 FDA UDI
K071331 FDA UDI
K071362 FDA UDI
K072821 FDA UDI
K121213 FDA UDI
K122578 FDA UDI
K140395 FDA UDI
K141302 FDA UDI
K143079 FDA UDI
K150104 FDA UDI
K151919 FDA UDI
FDA Product Code
JAK FDA UDI
LLZ FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
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 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

K032748 also covers:

K052632 also covers:

K071331 also covers:

K071362 also covers:

K072821 also covers:

K121213 also covers:

K122578 also covers:

K140395 also covers:

K141302 also covers:

K143079 also covers:

K150104 also covers:

K151919 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 a9f0323e-5e3a-40a2-a1ac-04a80a690d8a 34 fields · synced Jun 9, 2026