510(k) Report

FDA applicant

3D Industrial Imaging Co., Ltd.

Seoul, KR4 decisions2016–20200 recalls

FDA records 4 decisions for 3D Industrial Imaging Co., Ltd. (Seoul, KR) from 2016 to 2020: 4 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 171 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 6 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 3D Industrial Imaging Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016: 12018: 12019: 12020: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — 3D Industrial Imaging Co., Ltd. by year, 2016–2026Sources: 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

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 171 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 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.

  • K180629DentiqGuide3D Industrial Imaging Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K200078VARO Plan3D Industrial Imaging Co., Ltd. · 2020
  • K183676DentiqAir3D Industrial Imaging Co., Ltd. · 2019
  • K180629DentiqGuide3D Industrial Imaging Co., Ltd. · 2018
  • K160666Dentiq3D3D Industrial Imaging Co., Ltd. · 2016

All 4 as 3D Industrial Imaging Co., Ltd. →