| Primary Device ID | 00850057636024 |
| NIH Device Record Key | 00b85c60-52c9-4044-8868-b660b5aeb3cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | qXR-LN |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850057636024 [Primary] |
| MYN | Analyzer, Medical Image |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-02 |
| Device Publish Date | 2024-06-24 |
| 00850057636024 - qXR-LN | 2024-07-02The 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 |
| 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 | 2022-06-08 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 |