510(k) Report

FDA applicant

Nrt X-Ray A/S

Hasselager, DK2 decisions2018–20244 recalls

FDA records 2 decisions for Nrt X-Ray A/S (Hasselager, DK) from 2018 to 2024: 2 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 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 X-Ray A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2024

2022: 12023: 22024: 1
2018high 2 (2023) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Nrt X-Ray A/S by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nrt X-Ray A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System1decision
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K242948Adora DRFi (04550010)Nrt X-Ray A/S · 2024
  • K173631Intelli-CNrt X-Ray A/S · 20184 recalls

All 2 as Nrt X-Ray A/S →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K173631Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop…Apr 17, 2024Class II
  • K173631Intelli-C, Left side suspended Tabletop, REF: 03400010Apr 27, 2023Class II
  • K173631Intelli-C, Right side suspended Tabletop, REF: 03400000Apr 27, 2023Class II
  • K1736311. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support…Jan 21, 2022Class II