510(k) Report

FDA applicant

Imvaria, Inc.

Berkeley, CA3 decisions2024–20250 recalls

FDA records 3 decisions for Imvaria, Inc. (Berkeley, CA) from 2024 to 2025: 2 510(k) clearances and 1 De Novo grant. All are in product code QWO (Radiology Software For Referral Of Findings…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Imvaria, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024: 12025: 2
2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Imvaria, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Imvaria, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.3decisions

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN220040FibresolveImvaria, Inc. · 20243cite it

What has FDA decided for it lately?

  • K252041Fibresolve (with PCCP)Imvaria, Inc. · 2025
  • K241891ScreenDxImvaria, Inc. · 2025
  • DEN220040FibresolveImvaria, Inc. · 2024

All 3 as Imvaria, Inc. →