RapidiaColon System

GUDID 08809278790024

INFINITT Healthcare Co.,Ltd.

Radiology PACS software
Primary Device ID08809278790024
NIH Device Record Key3a56c03e-a740-493e-9ca4-49b38164e89e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapidiaColon System
Version Model NumberRapidiaColon System
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
GS108809278790024 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

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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