INFINITT Cardiology PACS

Primary DI
08809278790062
Brand
INFINITT Cardiology PACS
Company
INFINITT Healthcare Co.,Ltd.
Model
INFINITT Cardiology PACS
Published
2017-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K082706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082706000INFINITT CARDIOLOGY PACSInfinitt Co., Ltd.2008-11-06LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809278790062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809278790062088092787900628809278790062

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
688319156
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
false
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
08809278790000STARPACSSTARPACS2017-06-05
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
08809278790345INFINITT RT MobileINFINITT RT Mobile2022-08-25
08809278790192INFINITT RT PACSINFINITT RT PACS2021-11-18
08809278790307Xelis Dental 2.0Xelis Dental 2.02021-11-18
08809278790291INFINITT DPSINFINITT DPS2026-01-29

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Primary DI, Brand, Company table
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00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
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00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
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00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
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00817886020448JointsMEDSTRAT, INC.LLZ2022-06-17