Primary Device ID | 00860005118144 |
NIH Device Record Key | 0bf37045-4fd5-4c9c-a7a1-f0ea18a84703 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | qXR-BT |
Version Model Number | 1.0.0 |
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 |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai | |
Phone | +1(262)347-9734 |
support@qure.ai |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860005118144 [Primary] |
QIH | Automated Radiological Image Processing Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-06-08 |
Device Publish Date | 2022-05-31 |
00850057636024 - qXR-LN | 2024-07-02 The qXR-LN (qXR_Lung_nodule) is computer-aided detection software to identify and mark regions in relation to suspected pulmonar |
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 | 2022-06-08The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest X- rays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image. |
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 | 2020-12-14 Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for sign |