510(k) · Cleared
Cleared.Decimal Range Compensator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
.Decimal, Inc. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on May 22, 2007 as substantially equivalent to K040804 (Southeastern Radiation Products, Inc., 2004) after a 35-day review. Its family tree reaches back 3 generations to 2000. 9 later devices descend from it.
- Decided
- May 22, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000137 (2000). 7 ancestors in all, the oldest K880047 (1988). 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
- 2 generations backK021987 Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
- 1 generation backK040804 .Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004
- This deviceK071078 .Decimal Range Compensator.Decimal, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK091911 Bolus Compensator.Decimal, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK214093 VSP Bolus3D Systems · 2022
- Descendant · cites it directly · 2 of its ownK121657 Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion…Proton Systems · 2012
- Descendant · 3 generations on · 1 of its ownK222639 VHA Radiotherapy BolusVha Dean · 2022
- Descendant · 2 generations on · 1 of its ownK211511 decimal Bolus.Decimal, LLC · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K091911Bolus Compensator.Decimal, Inc. · 2009 · cites it directly5descendants
- K214093VSP Bolus3D Systems · 2022 · 2 generations on2descendants
- K121657Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range…Proton Systems · 2012 · cites it directly2descendants
- K222639VHA Radiotherapy BolusVha Dean · 2022 · 3 generations on1descendant
- K211511decimal Bolus.Decimal, LLC · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000137 | Enhanced Compensating Filter | Computerized Medical Systems, Inc. | 2000 | — |
| −2 | K021987 | Parcomplast Compensating Filter for Radiation Therapy | S&S Par Scientific | 2002 | — |
| −1 | K040804 | .Decimal Tissue Compensator/Intensity Modulator | Southeastern Radiation Products, Inc. | 2004 | — |
| 0 (this device) | K071078 | .Decimal Range Compensator | .Decimal, Inc. | 2007 | — |
| +1 | K091911 | Bolus Compensator | .Decimal, Inc. | 2009 | — |
| +2 | K214093 | VSP Bolus | 3D Systems | 2022 | — |
| +1 | K121657 | Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy… | Proton Systems | 2012 | — |
| +3 | K222639 | VHA Radiotherapy Bolus | Vha Dean | 2022 | — |
| +2 | K211511 | decimal Bolus | .Decimal, LLC | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 2 | 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 K253025 Ricoh 3D for Healthcare Bolusscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K040804 | .Decimal Tissue Compensator/Intensity ModulatorSummary page 1…mnal Range Compensator Classification Name: 'XI 21 CFR892.5710 Class LI Predicate Device(s): .decimnal, Inc. DECIMAL TISSUE COMPENSATOR /INTENSITY MODULATOR, 5 10k # K040804 Intended Use: .decimal's Range Compensator manufacturing service manufactures the solid Range Compensators for i… | 2004 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K091911 (.Decimal, Inc., 2009) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K040804.
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. 2007, 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?
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a…
Read the full statement (136 words)
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a
large "snout". The "snout" is rotated around the patient using a large, three-story
gantry. While the patient lies on a treatment table, the gantry rotates around and
points the snout at pre-determined positions to maximize efficiency and dose delivery
to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam
modifying, patient specific devices: a range compensator and an aperture.
The range compensator is made out of acrylic or wax. The custom shape/design
specifications for range compensators are generated out of the treatment planning
system and are unique to each patient and each gantry angle (most patients will have
2-3 different gantry angles.) The outer dimensions/specifications are vendor specific,
based upon the manufacturer of the proton delivery machines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071078: .Decimal Range Compensator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071078
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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