Clearance Summary
Ricoh 3D for Healthcare Bolus received FDA 510(k) clearance under submission number K253025, sponsored by Ricoh 3D For Healthcare, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-04-06.
- Submission: K253025
- Applicant / Sponsor: Ricoh 3D For Healthcare, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5710
- Decision date: 2026-04-06
Classification & Regulation
This clearance is catalogued under FDA product code IXI and 21 CFR 892.5710, within the Radiology review panel as a Class II device.