FDA.reportPublic FDA data

Vitrea View

Primary DI
00853866003308
Brand
Vitrea View
Company
Canon Medical Informatics, Inc.
Model
7.1.1
Published
2017-08-04
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
K163232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163232000Vitrea ViewVital Images, Inc.2017-07-21LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853866003308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853866003308008538660033088538660033080853866003308

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B745ELUCIDB1P1Elucid Plaque-IQELUCID BIOIMAGING INC.LLZ2026-10-29
04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
00889024671270ROSA® HipOrthosoft IncLLZ2026-10-27
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20