Quicktome Software Suite SCI0006

GUDID 09358140000055

Omniscient Neurotechnology Pty Ltd (o8t)

Radiology PACS software
Primary Device ID09358140000055
NIH Device Record Key85f732f8-8bf6-4888-a98b-5b50c22e9181
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuicktome Software Suite
Version Model Number2.1
Catalog NumberSCI0006
Company DUNS745431891
Company NameOmniscient Neurotechnology Pty Ltd (o8t)
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
GS109358140000055 [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 Date2023-08-03
Device Publish Date2023-07-26

Devices Manufactured by Omniscient Neurotechnology Pty Ltd (o8t)

09358140000055 - Quicktome Software Suite2023-08-03
09358140000055 - Quicktome Software Suite2023-08-03
09358140000048 - Quicktome2023-04-24
09358140000024 - Quicktome2022-05-18
09358140000017 - Quicktome2021-07-01

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