3DIEMME RealGUIDE— 510(k) K173041

Substantially Equivalent

3Diemme , Ltd.

FDA 510(k) clearance K173041 for 3DIEMME RealGUIDE, Substantially Equivalent on 2018-12-20. Applicant: 3Diemme , Ltd..

Clearance details

Applicant: 3Diemme , Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2017-09-28
Decision date: 2018-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cantu, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.