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® software is an advanced visualization solution from Vital that creates 2D, 3D, and 4D images of human anatomy from image data from multiple modalities. With this tool, physicians can easily navigate within these images to better understand disease conditions. Vitrea addresses specialists’ needs through various software options for cardiac, colon, vessel probe, and other applications. In addition, Vitrea software utilizes an intuitive clinical workflow and automatic settings to improve speed and simplicity. FDA UDI
Model / Reference: 7.3.2 FDA UDI
Description: Vitrea® software is an advanced visualization solution from Vital that creates 2D, 3D, and 4D images of human anatomy from image data from multiple modalities. With this tool, physicians can easily navigate within these images to better understand disease conditions. Vitrea addresses specialists’ needs through various software options for cardiac, colon, vessel probe, and other applications. In addition, Vitrea software utilizes an intuitive clinical workflow and automatic settings to improve speed and simplicity. FDA UDI

Identifiers

Primary DI / UDI-DI: 00853866003216 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
K151115 FDA UDI
K151283 FDA UDI
K151919 FDA UDI
K160150 FDA UDI
K161157 FDA UDI
K161419 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

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.

AVIEW — CORELINE SOFT CO., LTD. · Class II
ThinkingNet — THINKING SYSTEMS CORP. · Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
QuantX — Qlarity Imaging · Class II
interWORKS — Avreo, Inc. · Class I
NovaPACS — Novarad Corporation · Class II
OrthoNext™ Platform System Software — Orthofix, Inc. · Class II

Cleared under the same submission

K072821 also covers:

K150258 also covers:

K161419 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Canon Medical Informatics, Inc.

Sources (1)

FDA UDI 056965df-2235-4585-ac8a-9a14f516ab72 34 fields · synced Jun 9, 2026