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510(k) K253025

Ricoh 3D for Healthcare Bolus by Ricoh 3D For Healthcare, LLC — Product Code IXI

K253025 is an FDA 510(k) premarket notification submitted by Ricoh 3D For Healthcare, LLC for the device "Ricoh 3D for Healthcare Bolus". The FDA issued a decision of Substantially Equivalent on April 6, 2026. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2026
Date Received
September 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type

Other clearances for product code IXI

  • K222639 — VHA Radiotherapy Bolus (November 4, 2022)
  • K214093 — VSP Bolus (March 30, 2022)
  • K132236 — .DECIMAL PROTON APERTURE (October 16, 2013)
  • K131150 — CURA COMPENSATOR (July 30, 2013)
  • K123893 — CURA COLLIMATOR (March 4, 2013)
  • K123015 — .DECIMAL PHOTON BLOCK (November 21, 2012)
  • K111676 — APEX (September 30, 2011)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)

FDA data resources