510(k) Report

FDA applicant

Taihao Medical, Inc.

Taipei, TW4 decisions2016–20210 recalls

FDA records 4 decisions for Taihao Medical, Inc. (Taipei, TW) from 2016 to 2021: 4 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Taihao Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12017: 22021: 1
2016high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Taihao Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Taihao Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 209 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 0 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.

  • K210670BU-CADTaihao Medical, Inc. · 20213cite it
  • K171309BR-FHUS Navigation 1.0Taihao Medical, Inc. · 20171cites it
  • K171709BR-FHUS Viewer 1.0Taihao Medical, Inc. · 20171cites it
  • K151075BR-ABVS Viewer 1.0Taihao Medical, Inc. · 20161cites it

What has FDA decided for it lately?

  • K210670BU-CADTaihao Medical, Inc. · 2021
  • K171709BR-FHUS Viewer 1.0Taihao Medical, Inc. · 2017
  • K171309BR-FHUS Navigation 1.0Taihao Medical, Inc. · 2017
  • K151075BR-ABVS Viewer 1.0Taihao Medical, Inc. · 2016

All 4 as Taihao Medical, Inc. →