qXR-CTR

GUDID 00850057636000

qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.

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 Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID00850057636000
NIH Device Record Key87eacd95-b70c-4e92-be2e-ee77bed5d10a
Commercial Distribution StatusIn Commercial Distribution
Brand NameqXR-CTR
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
GS100850057636000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

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

00850057636000 - qXR-CTR2023-10-18qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities.
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 - qER2020-12-14 Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for sign
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.