INFINITT PACS

GUDID 08809278790130

INFINITT Healthcare Co.,Ltd.

Radiological PACS software
Primary Device ID08809278790130
NIH Device Record Keya0c8b253-623a-45de-9610-8257ccd2be8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINITT PACS
Version Model NumberINFINITT PACS 7.0
Company DUNS688319156
Company NameINFINITT Healthcare Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809278790130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-10-18
Device Publish Date2017-12-06

Devices Manufactured by INFINITT Healthcare Co.,Ltd.

08809278790000 - STARPACS2023-10-18
08809278790062 - INFINITT Cardiology PACS2023-10-18
08809278790079 - Xelis2023-10-18
08809278790086 - Xelis 3D2023-10-18
08809278790093 - Xelis Fusion2023-10-18
08809278790109 - Xelis Cardiac2023-10-18
08809278790116 - Xelis Dental2023-10-18
08809278790123 - INFINITT ULite2023-10-18

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