510(k) Report

FDA applicant

Miegmbh

Seth, DE4 decisions2010–20200 recalls

FDA records 4 decisions for Miegmbh (Seth, DE) from 2010 to 2020: 4 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 11 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 Miegmbh’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 22013: 12020: 1
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Miegmbh by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission4decisions

Whose devices does it build on?

Its devices cite 11 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.

  • K130269Ecat Scintron PetMiegmbh · 20131cites it
  • K101013Modification to Scintron IVMiegmbh · 20101cites it

What has FDA decided for it lately?

  • K201807AncorisMiegmbh · 2020
  • K130269Ecat Scintron PetMiegmbh · 2013
  • K101768Mie Scintron Gamma Camera SystemsMiegmbh · 2010
  • K101013Modification to Scintron IVMiegmbh · 2010

All 4 as Miegmbh →