RealGUIDE— 510(k) K253902

Substantially Equivalent

3DIEMME SRL

FDA 510(k) clearance K253902 for RealGUIDE, Substantially Equivalent on 2026-08-04. Applicant: 3DIEMME SRL. Device class: 2.

Clearance details

Applicant: 3DIEMME SRL
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-05
Decision date: 2026-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cantù, IT

Download summary PDF View on FDA.gov ↗

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