510(k) · Cleared
Cleared.Decimal Aperture
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 18, 2007 as substantially equivalent to K040804 (Southeastern Radiation Products, Inc., 2004) after a 31-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- May 18, 2007
- Review
- 31 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). 4 later devices descend from it, 2 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 deviceK071077 .Decimal Aperture.Decimal, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK121657 Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion…Proton Systems · 2012
- Descendant · 2 generations on · 0 of its ownK132236 .Decimal Proton Aperture.Decimal, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK131150 Cura CompensatorCura Medical Technologies, LLC · 2013
- Descendant · cites it directly · 0 of its ownK123893 Cura CollimatorCura Medical Technologies, LLC · 2013
Most influential descendants
Showing 4 of 4 · See all- K121657Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range…Proton Systems · 2012 · cites it directly2descendants
- K132236.Decimal Proton Aperture.Decimal, Inc. · 2013 · 2 generations on0descendants
- K131150Cura CompensatorCura Medical Technologies, LLC · 2013 · 2 generations on0descendants
- K123893Cura CollimatorCura Medical Technologies, LLC · 2013 · cites it directly0descendants
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) | K071077 | .Decimal Aperture | .Decimal, Inc. | 2007 | — |
| +1 | K121657 | Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy… | Proton Systems | 2012 | — |
| +2 | K132236 | .Decimal Proton Aperture | .Decimal, Inc. | 2013 | — |
| +2 | K131150 | Cura Compensator | Cura Medical Technologies, LLC | 2013 | — |
| +1 | K123893 | Cura Collimator | Cura Medical Technologies, LLC | 2013 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 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…evice Name: .decimal Aperture Classification Name: 'XI 21 CFR892.5710 Class II Predicate Device(s): .decimal, Inc. DECIMAL TISSUE COMPENSATOR / INTENSITY MODULATOR, K040804 Intended Use: .decimal's Aperture manufacturing service manufactures the solid apertures for intensity modulatio… | 2004 |
What descends from it? (4)
2 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, K121657 (Proton Systems, 2012) has gone furthest, with 2 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 (171 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 compensators and apertures.
The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. The aperture is a brass plate with a 2D pattern/hole cut out of it, which defines the area that is to be treated with the proton beam. Apertures 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/K071077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071077: .Decimal Aperture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071077
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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