FDA applicant

3Shape Medical A/S

Copenhagen, DK3 decisions2014–20200 recalls

FDA records 3 decisions for 3Shape Medical A/S (Copenhagen, DK) from 2014 to 2020: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 6 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 3Shape Medical A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — 3Shape Medical A/S by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3Shape Medical 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

Other applicant names beginning “3Shape”

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

3Shape A/S 8 3Shape TRIOS A/S 3

3Shape Medical 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?

Other applicant names beginning “3Shape”