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…
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.
Who Else Makes It
Registered in Beijing.
Record
Regulatory record for qER | Listed by | Qure.ai Technologies Private Limited, India |
| FDA product code | QAS |
| Device type | Radiological Computer-Assisted Triage And Notification Software |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2080 |
| Establishment | Manufacturer |
| 510(k) | K200921 |
| Record published | 2020-12-04 |
| Record revised | 2023-12-04 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.