FDA applicant

Danish Diagnostic Development A/S

Horsholm, DK6 decisions2000–20084 recalls

FDA records 6 decisions for Danish Diagnostic Development A/S (Horsholm, DK) from 2000 to 2008: 6 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). Its devices cite 5 predicates, 4 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 Danish Diagnostic Development A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Danish Diagnostic Development A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Danish”

FDA records each applicant name separately; these may or may not be the same firm.

Danish Dermatologic Development A/S 3

Danish Diagnostic Development A/S

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Danish”