510(k) Report

FDA applicant

Amcad Biomed Corporation

Taipei, TW5 decisions2017–20210 recalls

FDA records 5 decisions for Amcad Biomed Corporation (Taipei, TW) from 2017 to 2021: 5 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 257 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Amcad Biomed Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2017: 22018: 22021: 1
2017high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Amcad Biomed Corporation by year, 2017–2026Sources: 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, Radiological4decisions
  • QIHAutomated Radiological Image Processing Software1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 257 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 0 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 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.

  • K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation · 20181cites it
  • K203555AmCAD-UTAmcad Biomed Corporation · 20211cites it

What has FDA decided for it lately?

  • K203555AmCAD-UTAmcad Biomed Corporation · 2021
  • K180867AmCAD-UOAmcad Biomed Corporation · 2018
  • K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation · 2018
  • K162574AmCAD-USAmcad Biomed Corporation · 2017
  • K170069AmCAD-UVAmcad Biomed Corporation · 2017

All 5 as Amcad Biomed Corporation →