510(k) · Cleared
ClearedRicoh 3D for Healthcare Bolus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ricoh 3D For Healthcare, LLC · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Apr 6, 2026 as substantially equivalent to K222639 (Vha Dean, 2022) after a 199-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Apr 6, 2026
- Review
- 199 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000137 (2000). 11 ancestors in all, the oldest K880047 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
- 6 generations backK021987 Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
- 5 generations backK040804 .Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004
- 4 generations backK071078 .Decimal Range Compensator.Decimal, Inc. · 2007
- 3 generations backK091911 Bolus Compensator.Decimal, Inc. · 2009
- 2 generations backK214093 VSP Bolus3D Systems · 2022
- 1 generation backK222639 VHA Radiotherapy BolusVha Dean · 2022
- This deviceK253025 Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000137 | Enhanced Compensating Filter | Computerized Medical Systems, Inc. | 2000 | — |
| −6 | K021987 | Parcomplast Compensating Filter for Radiation Therapy | S&S Par Scientific | 2002 | — |
| −5 | K040804 | .Decimal Tissue Compensator/Intensity Modulator | Southeastern Radiation Products, Inc. | 2004 | — |
| −4 | K071078 | .Decimal Range Compensator | .Decimal, Inc. | 2007 | — |
| −3 | K091911 | Bolus Compensator | .Decimal, Inc. | 2009 | — |
| −2 | K214093 | VSP Bolus | 3D Systems | 2022 | — |
| −1 | K222639 | VHA Radiotherapy Bolus | Vha Dean | 2022 | — |
| 0 (this device) | K253025 | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IXI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IXI device
- #1 K222639 VHA Radiotherapy Bolusscore 8.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K222639 | VHA Radiotherapy BolusSummary page 5…CATE & REFERENCE DEVICES Predicate Manufacturer: VHA Office of Advanced Manufacturing - Ft. Lawton Predicate Trade Name: VHA Radiotherapy Bolus Predicate 510(k): K222639 IV. DEVICE DESCRIPTION The Ricoh 3D for Healthcare Bolus is a patient-specific device placed on the patient's skin as a radiot… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All IXI devicesIXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IXI
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IXI
90in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IXI
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXI
1in 2016
MAUDE reports naming product code IXI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 3 | 78 | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 2 | — | 1 | 28 |
| 2012 | 1 | — | 1 | 3 |
| 2013 | 3 | 90 | 2 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ricoh 3D for Healthcare Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. Ricoh 3D for Healthcare Boluses are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. The Ricoh 3D for Healthcare Bolus product must be verified and approved by the…
Read the full statement (134 words)
The Ricoh 3D for Healthcare Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. Ricoh 3D for Healthcare Boluses are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. The Ricoh 3D for Healthcare Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The Ricoh 3D for Healthcare Bolus is intended for patients of all ages receiving radiotherapy treatment.
Ricoh 3D for Healthcare Bolus was evaluated using 6 MV photons, 6 MeV electrons, and 9 MeV electrons and has not been assessed for use with protons or orthovoltage X-rays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253025 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253025: Ricoh 3D for Healthcare Bolus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253025
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026