510(k) Report

FDA applicant

Atlaim Corporation

Anyang-Si, KR2 decisions2012–20150 recalls

FDA records 2 decisions for Atlaim Corporation (Anyang-Si, KR) from 2012 to 2015: 2 510(k) clearances. All are in product code 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.

FDA’s records also spell it “Atlaim”.

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 Atlaim Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012: 12015: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Atlaim Corporation 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?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions

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 6 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.

  • K113812ATAL-8Atlaim · 20124cite it
  • K152151ATAL 9Atlaim Corporation · 20152cite it

What has FDA decided for it lately?

The one decision as Atlaim Corporation →The one decision as Atlaim →