qER

GUDID 00860005118106

Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for signs of intracranial hemorrhage, midline shift, mass effect or cranial fractures in order to prioritize them for clinical review. The standalone software device consists of an on-premise module and a cloud module. qER accepts non-contrast adult head CT scan DICOM files as input and provides a priority flag indicating critical scans.

QURE.AI TECHNOLOGIES PRIVATE LIMITED

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID00860005118106
NIH Device Record Key1d7974e1-5888-4ef9-82b4-47e0688a6443
Commercial Distribution StatusIn Commercial Distribution
Brand NameqER
Version Model Number2.0.0
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100860005118106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QASRadiological Computer-Assisted Triage And Notification Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-14
Device Publish Date2020-12-04

Devices Manufactured by QURE.AI TECHNOLOGIES PRIVATE LIMITED

00850057636000 - qXR-CTR2023-10-18 qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (C
00850057636017 - qXR-PTX-PE2023-10-18 qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the p
00860005118137 - qER-Quant2022-06-08 The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a
00860005118144 - qXR-BT2022-06-08 The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of
00860005118106 - qER2020-12-14Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for signs of intracranial hemorrhage, midline shift, mass effect or cranial fractures in order to prioritize them for clinical review. The standalone software device consists of an on-premise module and a cloud module. qER accepts non-contrast adult head CT scan DICOM files as input and provides a priority flag indicating critical scans.
00860005118106 - qER2020-12-14 Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for sign
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