510(k) Report

FDA applicant

Maxq AL, Ltd.

Tel Aviv, IL2 decisions2018–20200 recalls

FDA records 2 decisions for Maxq AL, Ltd. (Tel Aviv, IL) from 2018 to 2020: 2 510(k) clearances. All are in product code QAS (Radiological Computer-Assisted Triage And…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Maxq-Al , Ltd.”.

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 Maxq AL, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Maxq AL, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QASRadiological Computer-Assisted Triage And Notification Software2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K182177AccipiolxMaxq-Al, Ltd. · 20184cite it

What has FDA decided for it lately?

  • K201310AccipiolxMaxq AL, Ltd. · 2020
  • K182177AccipiolxMaxq-Al, Ltd. · 2018

The one decision as Maxq AL, Ltd. →The one decision as Maxq-Al, Ltd. →