FDA.reportPublic FDA data

Vitrea View

Primary DI
00853866003261
Brand
Vitrea View
Company
Canon Medical Informatics, Inc.
Model
7.0.1
Device description
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance. Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
Published
2017-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150738000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150738000VitreaViewVital Images, Inc.2015-04-06LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853866003261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853866003261008538660032618538660032610853866003261

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
160061651
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850025268431Vitrea Advanced Visualization7.16.52026-09-21
00850025268417Vitrea Advanced Visualization7.16.4.SU022026-06-05
00850025268257Vitrea Advanced Visualization7.16.12024-09-05
00850025268387Vitrea Advanced Visualization7.16.3.SU022025-11-03
00850025268424Vitrea Advanced Visualization7.16.3.SU032026-05-12
00850025268400Vitrea Advanced Visualization7.16.4.SU012026-02-27
00850025268394Vitrea Advanced Visualization7.16.42026-01-21
00850025268370Vitrea Advanced Visualization7.16.3.SU012025-09-24
00850025268349Vitrea Advanced Visualization7.16.32025-07-11
00850025268363Vitrea Advanced Visualization7.16.0.SU052025-06-03
00850025268356Vitrea Advanced Visualization7.16.2.SU022025-05-23
00850025268332Vitrea Advanced Visualization7.16.2.SU012025-05-16
00850025268318Vitrea Advanced Visualization7.16.22025-03-21
00850025268325Vitrea Advanced Visualization7.16.0.SU042024-11-21
00850025268301Vitrea Advanced Visualization7.16.0.SU032024-09-20
00850025268295Vitrea Advanced Visualization7.16.0.SU022024-08-13
00850025268240Vitrea Advanced Visualization7.16.0.SU012024-05-02
00850025268233Vitrea Advanced Visualization7.16.02024-04-12
00850025268226Vitrea Advanced Visualization7.15.8.SU012024-01-29
00850025268219Vitrea Advanced Visualization7.15.82023-10-13

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