Ricoh 3D for Healthcare Bolus— 510(k) K253025

Name: FDA 510(k) clearance K253025
Creator: U.S. Food and Drug Administration
Published: 2026-04-06

Substantially Equivalent

Ricoh 3D For Healthcare, LLC

FDA 510(k) clearance K253025 for Ricoh 3D for Healthcare Bolus, Substantially Equivalent on 2026-04-06. Applicant: Ricoh 3D For Healthcare, LLC. Device class: 2.

Clearance details

Applicant: Ricoh 3D For Healthcare, LLC
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2025-09-19
Decision date: 2026-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parma, OH, US

Download summary PDF View on FDA.gov ↗

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