510(k) Report

FDA applicant

Ezra Ai, Inc.

New York, NY3 decisions2020–20250 recalls

FDA records 3 decisions for Ezra Ai, Inc. (New York, NY) from 2020 to 2025: 3 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Ezra Ai, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 12023: 12025: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Ezra Ai, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software2decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 148 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K230264Ezra FlashEzra Ai, Inc. · 20231cites it

What has FDA decided for it lately?

  • K242334Ezra FlashEzra Ai, Inc. · 2025
  • K230264Ezra FlashEzra Ai, Inc. · 2023
  • K192969Ezra Plexo SoftwareEzra Ai, Inc. · 2020

All 3 as Ezra Ai, Inc. →