| Primary Device ID | 00850057636017 |
| NIH Device Record Key | 9abff555-38d6-4bdb-8b70-1fa98a88cb0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | qXR-PTX-PE |
| 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 | |
| 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 | 00850057636017 [Primary] |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-18 |
| Device Publish Date | 2023-10-10 |
| 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 | 2023-10-18qXR-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. |
| 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 |