510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253025Substantially Equivalent

Ricoh 3D for Healthcare Bolus

Ricoh 3D for Healthcare, LLC, Parma OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253025 is the FDA 510(k) clearance record for Ricoh 3D for Healthcare Bolus, a class II device, cleared for Ricoh 3D For Healthcare, LLC on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list one 510(k) clearance for Ricoh 3D For Healthcare, LLC. As of , FDA records show no recalls naming K253025.

Clearance record

Decision date
Received
(199 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
Ricoh 3D For Healthcare, LLC 5575 Venture Dr., Parma OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IXI

Trailing 12 months
1 clearance under product code IXI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IXI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260