Cleared Traditional

K253025 - Ricoh 3D for Healthcare Bolus

K253025 is an FDA 510(k) clearance for Ricoh 3D for Healthcare Bolus, manufactured by Ricoh 3D For Healthcare, LLC. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K253025 · Ricoh 3D For Healthcare, LLC · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
199d
Days
Class 2
Risk

K253025 is an FDA 510(k) clearance for the Ricoh 3D for Healthcare Bolus. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Ricoh 3D For Healthcare, LLC (Parma, US). The FDA issued a Cleared decision on April 6, 2026 after a review of 199 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ricoh 3D For Healthcare, LLC devices

FDA 510(k) Submission Details - K253025

510(k) Number K253025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date April 06, 2026
Days to Decision 199 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 107d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IXI Block, Beam-shaping, Radiation Therapy

All 28
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K253025.
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CURA COMPENSATOR
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CURA COLLIMATOR
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.DECIMAL PHOTON BLOCK
K123015 · .Decimal, Inc. · Nov 2012