← Product Code [IXI](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI) · K253025

# Ricoh 3D for Healthcare Bolus (K253025)

_Ricoh 3D For Healthcare, LLC · IXI · Apr 6, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K253025

## Device Facts

- **Applicant:** Ricoh 3D For Healthcare, LLC
- **Product Code:** [IXI](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI.md)
- **Decision Date:** Apr 6, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5710
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K253025](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K253025)

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