510(k) Report

FDA applicant

Nrt-Nordisk Rontgen Teknik A/S

Hasselager, DK1 decision2003–20037 recalls

FDA records 1 decision for Nrt-Nordisk Rontgen Teknik A/S (Hasselager, DK) in 2003: 1 510(k) clearance. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 1 predicate, 0 of them its own earlier devices. 7 recalls are 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 Nrt-Nordisk Rontgen Teknik A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nrt-Nordisk Rontgen Teknik A/S since 2007.

Recalls per year

1in 2015

2008: 42009: 12013: 12015: 1
2007high 4 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nrt-Nordisk Rontgen Teknik A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K033486GE Precision MpiNrt-Nordisk Rontgen Teknik A/S · 20031cites it

What has FDA decided for it lately?

  • K033486GE Precision MpiNrt-Nordisk Rontgen Teknik A/S · 20037 recalls

The one decision as Nrt-Nordisk Rontgen Teknik A/S →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K033486GE Healthcare, Precision MPi fluoroscopic imaging systems.Jun 12, 2015Class II
  • K033486GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The…Dec 12, 2013Class II
  • K033486Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray…May 1, 2009
  • K033486GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a…Jul 1, 2008Class II
  • K033486GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The…May 1, 2008
  • K033486GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The…May 1, 2008