Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
The radiology software for referral of findings related to fibrotic lung disease (product code QWO) is a prescription image processing device in the Radiology specialty (regulation 892.2085) that analyzes computed tomography images to suggest the presence of fibrotic lung disease or imaging findings suggestive of disease. Classified as Class 2, it requires 510(k) clearance. The output is intended as adjunctive information within a referral pathway and not as a standalone diagnostic tool. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QWO
- Device Class
- FDA class 2
- Regulation Number
- 892.2085
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252041 | Fibresolve (with PCCP) | Nov 07, 2025 | Substantially Equivalent | Imvaria, Inc. |
| K241891 | ScreenDx | Jan 10, 2025 | Substantially Equivalent | Imvaria, Inc. |
| K242467 | IQ-UIP | Dec 19, 2024 | Substantially Equivalent | Imbio, Inc. |
| DEN220040 | Fibresolve | Jan 12, 2024 | Unknown | Imvaria, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.