510(k) Report

FDA applicant

Aibolit Technologies, LLC

Delray Beach, FL2 decisions2022–20230 recalls

FDA records 2 decisions for Aibolit Technologies, LLC (Delray Beach, FL) from 2022 to 2023: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 1 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 Aibolit Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Aibolit Technologies, LLC by year, 2022–2026Sources: 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, Radiological2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K211443Aibolit 3D+Aibolit Technologies, LLC · 20222cite it

What has FDA decided for it lately?

  • K222458Aibolit 3D+Aibolit Technologies, LLC · 2023
  • K211443Aibolit 3D+Aibolit Technologies, LLC · 2022

All 2 as Aibolit Technologies, LLC →