qXR-PTX-PE

GUDID 00850057636017

qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, qXR-PTX-PE does not send a proactive alert directly to the appropriately trained medical specialists. qXR-PTX-PE is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

QURE.AI TECHNOLOGIES PRIVATE LIMITED

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Primary Device ID00850057636017
NIH Device Record Key9abff555-38d6-4bdb-8b70-1fa98a88cb0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameqXR-PTX-PE
Version Model Number1.0.0
Company DUNS860393884
Company NameQURE.AI TECHNOLOGIES PRIVATE LIMITED
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

Customer Support Contacts

Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai
Phone+1(262)347-9734
Emailsupport@qure.ai

Device Identifiers

Device Issuing AgencyDevice ID
GS100850057636017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFMRadiological Computer-Assisted Prioritization Software For Lesions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-18
Device Publish Date2023-10-10

Devices Manufactured by QURE.AI TECHNOLOGIES PRIVATE LIMITED

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00850057636017 - qXR-PTX-PE2023-10-18qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, qXR-PTX-PE does not send a proactive alert directly to the appropriately trained medical specialists. qXR-PTX-PE is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
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