qure.aiqCT LN Quant
Qure.Ai Technologies
QURE.AI TECHNOLOGIES INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017699515 | 3017699515 | QURE.AI TECHNOLOGIES INC | 1 | Y | 2026-01-01 | Suite 76J, One World Trade Center, New York, NY 10007 Church Street NY US 10007 |
| 3017840913 | 3017840913 | QURE.AI TECHNOLOGIES PRIVATE LIMITED | 1 | N | 2026-01-01 | 6th Floor, Wing E, Times Square Andheri-Kurla Road, Marol, Andheri (East), Mumbai Maharashtra IN 400059 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850057636000 | qXR-CTR - 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. | +1(262)347-9734 | support@qure.ai |
| 00850057636017 | qXR-PTX-PE - 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. | +1(262)347-9734 | support@qure.ai |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 283097 | 1922825548 | K240740 | qCT LN Quant | QIH | 2024-08-16 |
| 283097 | 1642400947 | K231805 | qXR-LN | MYN | 2023-12-22 |
| 283097 | 1168752387 | K231149 | qXR-CTR | QIH | 2023-09-22 |
| 283097 | 1561121802 | K230899 | qXR-PTX-PE | QFM | 2023-08-22 |
| 283097 | 1196793552 | K212690 | qXR-BT | QIH | 2021-12-21 |
| 283097 | 1824041825 | K211222 | qER-Quant | QIH | 2021-07-30 |
| 283097 | 1866232308 | K200921 | qER | QAS | 2020-06-17 |
| 283097 | 1771044767 |
Product Codes Associated With Registrations#
PMN#
GUDID#
qXR-LN - The qXR-LN (qXR_Lung_nodule) is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30 mm in size. The device is intended to be used in the incidental adult population. It is designed to aid the physician to review the frontal (AP/PA) chest radiographs of adults acquired on digital radiographic systems as a second reader and be used with any DICOM viewer or PACS . qXR-LN provides adjunctive information only and is not a substitute for the original chest radiographic image
2024-06-24
qER - 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.
2020-12-04
qXR-BT - The 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.
2022-05-31
qER-Quant - The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images.
2022-05-31
qXR-PTX-PE - 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.
2023-10-10
qXR-CTR - 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.
2023-10-10