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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 multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea system provides multi-dimensional 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, including: Retrieve image data over the network via DICOM, Display images that are automatically adapted to exam type via dedicated protocols, Select images for closer examination from a gallery of up to six 2D or 3D views, Interactively manipulate an image in real-time to visualize anatomy and pathology, Annotate, tag, measure, and record selected views, Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device, Retrieve reports that are archived on a Web server. FDA UDI
Model / Reference
7.4 FDA UDI
Description
Vitrea 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. The Vitrea system provides multi-dimensional 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, including: Retrieve image data over the network via DICOM, Display images that are automatically adapted to exam type via dedicated protocols, Select images for closer examination from a gallery of up to six 2D or 3D views, Interactively manipulate an image in real-time to visualize anatomy and pathology, Annotate, tag, measure, and record selected views, Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device, Retrieve reports that are archived on a Web server. FDA UDI

Identifiers

Primary DI / UDI-DI
00853866003186 FDA UDI
510(k) Number
K032748 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
K150258 FDA UDI
K151283 FDA UDI
K151919 FDA UDI
K160150 FDA UDI
K161157 FDA UDI
K161419 FDA UDI
FDA Product Code
LLZ FDA UDI
JAK FDA UDI
GMDN Term
Radiological PACS software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
892.1750 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:

K150258 also covers:

K151283 also covers:

K151919 also covers:

K160150 also covers:

K161157 also covers:

K161419 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 1e7b38b5-2786-44f1-b4d4-45675e633189 34 fields · synced Jun 9, 2026