FDA.reportPublic FDA data

Synthesis Vision Viewer

Primary DI
75401622502240
Brand
Synthesis Vision Viewer
Company
Synthesis Health Intelligence Inc
Model
2.4
Published
2025-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
75401622502240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7540162250224075401622502240

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Regulatory Flags#

DUNS number
243267198
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
75401622522101Synthesis Vision Viewer2.102026-05-27
75401622502295Synthesis Vision Viewer2.92026-04-22
75401622502288Synthesis Vision Viewer2.82026-03-17
75401622502271Synthesis Vision Viewer2.72026-02-10
75401622502264Synthesis Vision Viewer2.62025-12-23
75401622502257Synthesis Vision Viewer2.52025-12-12
75401622502226Synthesis Vision Viewer2.22025-09-15
75401622502202Synthesis Vision Viewer2.02025-07-25
75401622500208Synthesis Vision Viewer1.0.02024-10-07
75401622502233Synthesis Vision Viewer2.32025-10-13
75401622502219Synthesis Vision Viewer2.12025-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
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00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
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00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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00889024699823ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00860012615308Denti.AI Auto-ChartDenti.AI Technology IncLLZ2026-06-24
00860012615315Denti.AI DetectDenti.AI Technology IncLLZ2026-06-24
00850631008872Roentgen WorksBrit Systems, LLCLLZ2026-06-23
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05