qER

GUDID 00860005118106

Radiology DICOM image processing application software

Primary Device ID	00860005118106
NIH Device Record Key	1d7974e1-5888-4ef9-82b4-47e0688a6443
Commercial Distribution Status	In Commercial Distribution
Brand Name	qER
Version Model Number	2.0.0
Company DUNS	860393884
Company Name	QURE.AI TECHNOLOGIES PRIVATE LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00860005118106 [Primary]

QAS	Radiological Computer-Assisted Triage And Notification Software

Steralize Prior To Use	false
Device Is Sterile	false

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00850057636000 - qXR-CTR	2023-10-18 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-PE	2023-10-18 qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the p
00860005118137 - qER-Quant	2022-06-08 The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a
00860005118144 - qXR-BT	2022-06-08 The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of
00860005118106 - qER	2020-12-14Qure.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 - qER	2020-12-14 Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for sign