510(k) K241891
K241891 is an FDA 510(k) premarket notification submitted by Imvaria, Inc. for the device "ScreenDx". The FDA issued a decision of Substantially Equivalent on Jan 10, 2025. The device falls under product code QWO (Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.), a Class II device regulated under 21 CFR 892.2085. Imvaria, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 2025
- Date Received
- Jun 28, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
- Device Class
- Class II
- Regulation Number
- 892.2085
- Review Panel
- RA
- Submission Type
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.