RealGUIDE— 510(k) K253902

Name: FDA 510(k) clearance K253902
Creator: U.S. Food and Drug Administration
Published: 2026-08-04

Substantially Equivalent

3DIEMME SRL

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

Summary

3DIEMME's RealGUIDE is filed under product code QIH, automated radiological image processing software. The record has no description beyond the name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

3DIEMME filed from Cantù, Italy. The substantially equivalent decision came 242 calendar days after receipt (December 5, 2025 to August 4, 2026).

Clearance details

Applicant: 3DIEMME SRL
Product code: Product 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.