510(k) Report

FDA applicant

Mim Software, Inc.

Cleveland, OH22 decisions2011–20260 recalls

FDA records 22 decisions for Mim Software, Inc. (Cleveland, OH) from 2011 to 2026: 22 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QKB (Radiological Image Processing Software For…). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 43 predicates, 25 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 Mim Software, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2011: 32016: 12017: 12018: 22019: 12020: 12021: 12022: 22023: 32024: 42025: 22026 (partial year): 1
2011high 4 (2024) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Mim Software, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mim Software, 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?

  • LLZSystem, Image Processing, Radiological14decisions
  • QKBRadiological Image Processing Software For Radiation Therapy7decisions
  • QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation1decision

How long do its 510(k) reviews take?

Since 2016, its 18 510(k)s took a median of 133 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 131 days; 8 of its 18 were faster than that.

Whose devices does it build on?

Its devices cite 43 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 47 times; 25 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.

  • K103785Mobile MimMim Software, Inc. · 20118cite it
  • K103576Mim 5.2 (Brachy)Mim Software, Inc. · 20117cite it
  • K112930Mobile MimMim Software, Inc. · 20116cite it
  • K182624MIM - MRT DosimetryMim Software, Inc. · 20185cite it
  • K172218MIM – Y90 DosimetryMim Software, Inc. · 20174cite it
  • K190379MIM on LinuxMim Software, Inc. · 20193cite it

What has FDA decided for it lately?

  • K253270Contour ProtégéAI+Mim Software, Inc. · 2026
  • K251883MIM – LesionID ProMim Software, Inc. · 2025
  • K250035Contour ProtégéAI+Mim Software, Inc. · 2025
  • K243012MIM – Symphony HDR FusionMim Software, Inc. · 2024
  • K233620MIM - Centiloid ScalingMim Software, Inc. · 2024
  • K232862MIM – Monte Carlo DosimetryMim Software, Inc. · 2024
  • K232514MIM – Dose AnalysisMim Software, Inc. · 2024
  • K231765Contour ProtégéAIMim Software, Inc. · 2023

All 22 as Mim Software, Inc. →