510(k) Report

FDA applicant

Hdx Will Corp.

Cheongju-Si, KR9 decisions2016–20210 recalls

FDA records 9 decisions for Hdx Will Corp. (Cheongju-Si, KR) from 2016 to 2021: 9 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 189 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 4 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 Hdx Will Corp.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2016: 12017: 12018: 22019: 22021: 3
2016high 3 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like Hdx Will Corp.’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?

  • OASX-Ray, Tomography, Computed, Dental3decisions
  • LLZSystem, Image Processing, Radiological3decisions
  • EHDUnit, X-Ray, Extraoral With Timer2decisions
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 189 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; 2 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 4 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.

  • K160140DENTRIa seriesHdx Will Corp. · 20164cite it
  • K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 20181cites it
  • K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp. · 20211cites it
  • K170180Will3DHdx Will Corp. · 20171cites it

What has FDA decided for it lately?

  • K211159eco-x Series (eco-x, eco-x-s)Hdx Will Corp. · 2021
  • K211114Will3DHdx Will Corp. · 2021
  • K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp. · 2021
  • K192700XcamHdx Will Corp. · 2019
  • K190357Star-X, Intraoral X-ray SystemHdx Will Corp. · 2019
  • K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
  • K172168WillCephHdx Will Corp. · 2018
  • K170180Will3DHdx Will Corp. · 2017

All 9 as Hdx Will Corp. →