Mumbai, IN · 9 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 4 | 2024-08-16 |
| MYN | Analyzer, Medical Image | Class II | Radiology | 2 | 2026-01-16 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | Class II | Radiology | 2 | 2025-09-08 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | Class II | Radiology | 1 | 2023-08-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-16 | K251934 | qXR-Detect | MYN | Class II | Radiology |
| 2025-09-08 | K251610 | qER-CTA (v1.0) | QAS | Class II | Radiology |
| 2024-08-16 | K240740 | qCT LN Quant | QIH | Class II | Radiology |
| 2023-12-22 | K231805 | qXR-LN | MYN | Class II | Radiology |
| 2023-09-22 | K231149 | qXR-CTR | QIH | Class II | Radiology |
| 2023-08-22 | K230899 | qXR-PTX-PE | QFM | Class II | Radiology |
| 2021-12-21 | K212690 | qXR-BT | QIH | Class II | Radiology |
| 2021-07-30 | K211222 | qER-Quant | QIH | Class II | Radiology |
| 2020-06-17 | K200921 | qER | QAS | Class II | Radiology |