510(k) Report

FDA applicant

Wide Corporation

Yongin-Si, KR20 decisions2003–20230 recalls

FDA records 20 decisions for Wide Corporation (Yongin-Si, KR) from 2003 to 2023: 20 510(k) clearances. Most are in product codes PGY (Display, Diagnostic Radiology) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 30 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 5 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 Wide Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2011: 12016: 62017: 22021: 22022: 22023: 2
2007high 6 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wide Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PGYDisplay, Diagnostic Radiology14decisions
  • LLZSystem, Image Processing, Radiological6decisions

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 30 days; 6 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K052312Wide 5MP (Mammo) LCD Monitor SystemWide Corporation · 20052cite it
  • K032174Wide 3MP Grayscale TFT LCD Monitor IF2103AWide Corporation · 20032cite it
  • K032960Wide 2MP TFT LCD Monitor System IF 1902AWide Corporation · 20031cites it
  • K170781MX50N (MX50YQS)Wide Corporation · 20171cites it
  • K170783CX50N (CX50YQS)Wide Corporation · 20171cites it

What has FDA decided for it lately?

  • K222719CX50NWide Corporation · 2023
  • K222716MX50NWide Corporation · 2023
  • K222717CL24NWide Corporation · 2022
  • K222722CW60NWide Corporation · 2022
  • K210493CX30N (CX30PQX)Wide Corporation · 2021
  • K210491CW120NWide Corporation · 2021
  • K170781MX50N (MX50YQS)Wide Corporation · 2017
  • K170783CX50N (CX50YQS)Wide Corporation · 2017

All 20 as Wide Corporation →