510(k) Report

FDA applicant

3Diemme, Ltd.

Cantu, IT2 decisions2018–20260 recalls

FDA records 2 decisions for 3Diemme, Ltd. (Cantu, IT) from 2018 to 2026: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “3DIEMME SRL”.

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 3Diemme, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — 3Diemme, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3Diemme, Ltd.’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?

  • LLZSystem, Image Processing, Radiological1decision
  • QIHAutomated Radiological Image Processing Software1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K1730413DIEMME RealGUIDE3Diemme, Ltd. · 20182cite it

What has FDA decided for it lately?

  • K253902RealGUIDE3DIEMME SRL · 2026
  • K1730413DIEMME RealGUIDE3Diemme, Ltd. · 2018

The one decision as 3Diemme, Ltd. →The one decision as 3DIEMME SRL →