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FDA 510(k)

Ricoh 3D for Healthcare Bolus

K-Number: K253025 · 2026-04-06

Decision Date2026-04-06
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ricoh 3D for Healthcare Bolus is the device name listed in this FDA 510(k) record. The listed applicant is Ricoh 3D For Healthcare, LLC. It received FDA 510(k) clearance on 2026-04-06 under 510(k) 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. The listed applicant is Ricoh 3D For Healthcare, LLC. The 510(k) number is K253025.

When did Ricoh 3D for Healthcare Bolus receive FDA 510(k) clearance?

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

Who is the listed applicant for Ricoh 3D for Healthcare Bolus?

The FDA 510(k) record lists Ricoh 3D For Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: IXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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