QWO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2085
- Medical specialty
- Radiology
- FDA definition
- Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
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| Record | Firm | Date |
|---|---|---|
| Fibresolve (with PCCP) (K252041) | Imvaria, Inc. | 2025-11-07 |
| ScreenDx (K241891) | Imvaria, Inc. | 2025-01-10 |
| IQ-UIP (K242467) | Imbio, Inc. | 2024-12-19 |
| Fibresolve (DEN220040) | Imvaria, Inc. | 2024-01-12 |
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