510(k) Report

FDA applicant

Microstructure Imaging, Inc.

Brooklyn, NY2 decisions2024–20260 recalls

FDA records 2 decisions for Microstructure Imaging, Inc. (Brooklyn, NY) from 2024 to 2026: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and KPS (System, Tomography, Computed, Emission). Its devices cite 2 predicates, 0 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 Microstructure Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 12026 (partial year): 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

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

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision
  • KPSSystem, Tomography, Computed, Emission1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K261305Micsi-PetMicrostructure Imaging, Inc. · 2026
  • K241121Micsi-RMTMicrostructure Imaging, Inc. · 2024

All 2 as Microstructure Imaging, Inc. →