510(k) Report

FDA applicant

Ddd-Diagnostic A/S

Horsholm, DK2 decisions2014–20160 recalls

FDA records 2 decisions for Ddd-Diagnostic A/S (Horsholm, DK) from 2014 to 2016: 2 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). 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, radiology panel, where it files most

How often FDA has decided Ddd-Diagnostic A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Ddd-Diagnostic A/S by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ddd-Diagnostic 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?

  • KPSSystem, Tomography, Computed, Emission2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 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.

  • K140206Scintillation Gamma CameraDdd-Diagnostic A/S · 20141cites it

What has FDA decided for it lately?

  • K161674QuantumCamDdd-Diagnostic A/S · 2016
  • K140206Scintillation Gamma CameraDdd-Diagnostic A/S · 2014

All 2 as Ddd-Diagnostic A/S →