510(k) Report

FDA applicant

Imbio, LLC

Minneapolis, MN6 decisions2014–20240 recalls

FDA records 6 decisions for Imbio, LLC (Minneapolis, MN) from 2014 to 2024: 6 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Imbio, Inc.”.

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 Imbio, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2014: 12018: 12021: 12023: 12024: 2
2014high 2 (2024) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Imbio, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Imbio, LLC’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?

  • QIHAutomated Radiological Image Processing Software2decisions
  • JAKSystem, X-Ray, Tomography, Computed2decisions
  • LLZSystem, Image Processing, Radiological1decision
  • QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K203256Imbio RV/LV SoftwareImbio, LLC · 20216cite it

What has FDA decided for it lately?

  • K242467IQ-UIPImbio, Inc. · 2024
  • K241847Imbio PHA (4.0.0)Imbio, Inc. · 2024
  • K230112CAC SoftwareImbio, Inc. · 2023
  • K203256Imbio RV/LV SoftwareImbio, LLC · 2021
  • K180129Imbio Segmentation Editing Tool softwareImbio, LLC · 2018
  • K141069Lung Density AnalysisImbio, LLC · 2014

All 3 as Imbio, LLC →All 3 as Imbio, Inc. →