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510(k) K252041

Fibresolve (with PCCP) by Imvaria, Inc. — Product Code QWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2025
Date Received
June 30, 2025
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.

Other clearances by Imvaria, Inc.

  • K241891 — ScreenDx (January 10, 2025)
  • DEN220040 — Fibresolve (January 12, 2024)

Other clearances for product code QWO

  • K241891 — ScreenDx (January 10, 2025)
  • K242467 — IQ-UIP (December 19, 2024)
  • DEN220040 — Fibresolve (January 12, 2024)