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FDA 510(k)

Ricoh 3D for Healthcare Bolus

K-Number: K253025 · 2026-04-06

ApplicantRicoh 3D For Healthcare, LLC
Decision Date2026-04-06
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ricoh 3D for Healthcare Bolus is a medical device manufactured by Ricoh 3D For Healthcare, LLC. It received FDA 510(k) clearance on 2026-04-06 under approval number K253025. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ricoh 3D for Healthcare Bolus?

Ricoh 3D for Healthcare Bolus is a medical device that received FDA 510(k) clearance on 2026-04-06. It is manufactured by Ricoh 3D For Healthcare, LLC. The 510(k) number is K253025.

When was Ricoh 3D for Healthcare Bolus approved by the FDA?

Ricoh 3D for Healthcare Bolus received FDA 510(k) clearance on 2026-04-06, under approval number K253025.

What company makes Ricoh 3D for Healthcare Bolus?

Ricoh 3D for Healthcare Bolus is manufactured by Ricoh 3D For Healthcare, LLC.

What is the FDA product code for Ricoh 3D for Healthcare Bolus?

The FDA product code for Ricoh 3D for Healthcare Bolus is IXI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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