FDA.report

Quicktome Software Suite

Primary DI
09358140000055
Brand
Quicktome Software Suite
Company
Omniscient Neurotechnology Pty Ltd (o8t)
Model
2.1
Catalog number
SCI0006
Published
2023-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions

SubmissionSupplement
K222359000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222359000Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (O8t)2023-05-30LLZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09358140000055PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
745431891
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 DIBrandModelCatalogPublished
09358140000079Quicktome Software Suite2.3SCI00062026-03-09
09358140000062Quicktome Software Suite2.2SCI00062025-07-28
09358140000048Quicktome1.3SCI00012023-04-14
09358140000024Quicktome1.2SCI00012022-05-10
09358140000017Quicktome1.1SCI00012021-06-23

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