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.

Summary

The Ricoh 3D for Healthcare Bolus, from Ricoh 3D For Healthcare, LLC, is filed under product code IXI (Block, Beam-Shaping, Radiation Therapy).

Class II, 21 CFR 892.5710. It came in as a Traditional 510(k), and Radiology is both the classification panel and the review panel.

Ricoh 3D For Healthcare filed from Parma, Ohio. Review took 199 calendar days (September 19, 2025 to April 6, 2026).

Clearance details

Applicant: Ricoh 3D For Healthcare, LLC
Product code: Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.