FDA.reportPublic FDA data

INFINITT RT Mobile

Primary DI
08809278790345
Brand
INFINITT RT Mobile
Company
INFINITT Healthcare Co.,Ltd.
Model
INFINITT RT Mobile
Published
2022-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809278790345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809278790345088092787903458809278790345

GMDN Terms#

Term, Definition table
TermDefinition
Radiology 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. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688319156
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809278790291INFINITT DPSINFINITT DPS2026-01-29
08809278790000STARPACSSTARPACS2017-06-05
08809278790062INFINITT Cardiology PACSINFINITT Cardiology PACS2017-09-19
08809278790079XelisXelis2017-09-19
08809278790086Xelis 3DXelis 3D2017-09-19
08809278790093Xelis FusionXelis Fusion2017-09-19
08809278790109Xelis CardiacXelis Cardiac2017-09-19
08809278790116Xelis DentalXelis Dental2017-07-06
08809278790123INFINITT ULiteINFINITT ULite2017-07-06
08809278790130INFINITT PACSINFINITT PACS 7.02017-12-06
08809278790017STARPACS Orthopedics SystemSTARPACS Orthopedics System2023-06-09
08809278790024RapidiaColon SystemRapidiaColon System2023-06-09
08809278790031STARPACS DentalSTARPACS Dental2023-06-09
08809278790048Reformat GatewayReformat Gateway2023-06-09
08809278790055INFINITT PACS, INFINITT G3, INFINITT MammoINFINITT PACS2017-06-05
08809278790192INFINITT RT PACSINFINITT RT PACS2021-11-18
08809278790307Xelis Dental 2.0Xelis Dental 2.02021-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21
00850013331093SentiARSentiar, Inc.LMD2025-11-21
00850013331109SentiARSentiar, Inc.LMD2025-11-21
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00850025268387Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-11-03
00850025268370Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-09-24
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01