510(k) Report

FDA applicant

Pixxgen Corporation

Anyang-Si, KR4 decisions2018–20210 recalls

FDA records 4 decisions for Pixxgen Corporation (Anyang-Si, KR) from 2018 to 2021: 4 510(k) clearances. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 31 days from receipt to decision, against 30 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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 Pixxgen Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 22019: 12021: 1
2018high 2 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Pixxgen Corporation by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 31 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; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 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.

  • K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation · 20181cites it
  • K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation · 20181cites it

What has FDA decided for it lately?

  • K211108Prudent 1717, Prudent 1417, Prudent 1212Pixxgen Corporation · 2021
  • K190691Pixx2430 Digital Diagnostic X-Ray Receptor PanelPixxgen Corporation · 2019
  • K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation · 2018
  • K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation · 2018

All 4 as Pixxgen Corporation →