510(k) Report

FDA applicant

Prexion Corporation

Chiyoda-Ku, JP9 decisions2016–20230 recalls

FDA records 9 decisions for Prexion Corporation (Chiyoda-Ku, JP) from 2016 to 2023: 9 510(k) clearances. All are in product code OAS (X-Ray, Tomography, Computed, Dental). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 77 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 8 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 Prexion Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2016: 12018: 22019: 12020: 12021: 12022: 12023: 2
2016high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Prexion Corporation 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?

  • OASX-Ray, Tomography, Computed, Dental9decisions

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 77 days; 6 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 8 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.

  • K203784PreXion3D Explorer PROPrexion Corporation · 20212cite it
  • K190320PreXion3D ExplorerPrexion Corporation · 20192cite it
  • K193329PreXion3D Explorer EXPrexion Corporation · 20202cite it
  • K221525PreXion3D Explorer PROPrexion Corporation · 20221cites it
  • K161881PreXion3D ExcelsiorPrexion Corporation · 20161cites it
  • K222150PreXion3D ExpeditionPrexion Corporation · 20231cites it

What has FDA decided for it lately?

  • K232166PreXion3D ExpeditionPrexion Corporation · 2023
  • K222150PreXion3D ExpeditionPrexion Corporation · 2023
  • K221525PreXion3D Explorer PROPrexion Corporation · 2022
  • K203784PreXion3D Explorer PROPrexion Corporation · 2021
  • K193329PreXion3D Explorer EXPrexion Corporation · 2020
  • K190320PreXion3D ExplorerPrexion Corporation · 2019
  • K181983PreXion 3D ExcelsiorPrexion Corporation · 2018
  • K173878PreXion3D ExcelsiorPrexion Corporation · 2018

All 9 as Prexion Corporation →