510(k) Report

FDA applicant

Humanray Co,Ltd

Houston, TX2 decisions2012–20120 recalls

FDA records 2 decisions for Humanray Co,Ltd (Houston, TX) in 2012: 2 510(k) clearances. Most are in product codes EAP (Unit, X-Ray, Intraoral) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 2 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, dental panel, where it files most

How often FDA has decided Humanray Co,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2012: 2
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Humanray Co,Ltd by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EAPUnit, X-Ray, Intraoral1decision
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K121132Ezsensor P Digital Intraoral SensorHumanray Co,Ltd · 20122cite it
  • K113360Medical Image Processing UnitHumanray Co,Ltd · 20121cites it

What has FDA decided for it lately?

  • K121132Ezsensor P Digital Intraoral SensorHumanray Co,Ltd · 2012
  • K113360Medical Image Processing UnitHumanray Co,Ltd · 2012

All 2 as Humanray Co,Ltd →