510(k) · Cleared

Cleared

.Decimal Tissue Compensator/Intensity Modulator

K040804510(k) TraditionalCleared Apr 28, 200430-day reviewClass II21 CFR 892.5710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Southeastern Radiation Products, Inc. · IXI Block, Beam-Shaping, Radiation Therapy

Cleared on Apr 28, 2004 as substantially equivalent to K000137 (Computerized Medical Systems, Inc., 2000) and 4 other predicates after a 30-day review. Its family tree reaches back 2 generations to 2000. 15 later devices descend from it.

Decided: Apr 28, 2004
Review: 30 days
Class: Class II
Product code: IXI
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K000137 (2000). 6 ancestors in all, the oldest K880047 (1988). 15 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK000137 Enhanced Compensating FilterComputerized Medical Systems, Inc. · 2000
1 generation backK021987 Parcomplast Compensating Filter for Radiation TherapyS&S Par Scientific · 2002
This deviceK040804 .Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc. · 2004
Descendant · cites it directly · 9 of its ownK071078 .Decimal Range Compensator.Decimal, Inc. · 2007
Descendant · 2 generations on · 5 of its ownK091911 Bolus Compensator.Decimal, Inc. · 2009
Descendant · cites it directly · 4 of its ownK071077 .Decimal Aperture.Decimal, Inc. · 2007
Descendant · 3 generations on · 2 of its ownK214093 VSP Bolus3D Systems · 2022
Descendant · 2 generations on · 2 of its ownK121657 Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion…Proton Systems · 2012

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006high 3 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 15 · See all

K071078.Decimal Range Compensator.Decimal, Inc. · 2007 · cites it directly9descendants
K091911Bolus Compensator.Decimal, Inc. · 2009 · 2 generations on5descendants
K071077.Decimal Aperture.Decimal, Inc. · 2007 · cites it directly4descendants
K214093VSP Bolus3D Systems · 2022 · 3 generations on2descendants
K121657Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range…Proton Systems · 2012 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000137	Enhanced Compensating Filter	Computerized Medical Systems, Inc.	2000	—
−1	K021987	Parcomplast Compensating Filter for Radiation Therapy	S&S Par Scientific	2002	—
0 (this device)	K040804	.Decimal Tissue Compensator/Intensity Modulator	Southeastern Radiation Products, Inc.	2004	—
+1	K071078	.Decimal Range Compensator	.Decimal, Inc.	2007	—
+2	K091911	Bolus Compensator	.Decimal, Inc.	2009	—
+1	K071077	.Decimal Aperture	.Decimal, Inc.	2007	—
+3	K214093	VSP Bolus	3D Systems	2022	—
+2	K121657	Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy…	Proton Systems	2012	—

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
2006	2	0
2007	2	0
2009	2	0
2012	1	0
2013	3	0
2021	1	0
2022	2	0
2026	2	0

FIG. 1 — Lineage of K040804, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K000137	Enhanced Compensating Filter Summary page 1 …om Device Name: .decimal tissue compensator / intensity modulator manufacturing service Classification Name: Class II Predicate Device(s): CMS K0000137 NOMOS K9404 12 (as referred to in CMS' 5 10(k) submission) Varian K943224 (as r…	Computerized Medical Systems, Inc.	2000	—
*	K940412	Multileaf Intensity Modulating Collimator Summary page 1 …sue compensator / intensity modulator manufacturing service Classification Name: Class II Predicate Device(s): CMS K0000137 NOMOS K9404 12 (as referred to in CMS' 5 10(k) submission) Varian K943224 (as referred to in CMS' 5 10(k) submi…	Nomos Corp.	1995	—
*	K943224	Varian Multileaf Collimator Summary page 1 …lass II Predicate Device(s): CMS K0000137 NOMOS K9404 12 (as referred to in CMS' 5 10(k) submission) Varian K943224 (as referred to in CMS' 5 10(k) submission) PAR Scientific K02 1987 Huestis K880047 === Page 2 =…	Varian Assoc., Inc.	1996	2
*	K021987	Parcomplast Compensating Filter for Radiation Therapy Summary page 1 …K9404 12 (as referred to in CMS' 5 10(k) submission) Varian K943224 (as referred to in CMS' 5 10(k) submission) PAR Scientific K02 1987 Huestis K880047 Intended Use: .decimal tissue compensator/intensity modulator manufacturing servi…	S&S Par Scientific	2002	—
*	K880047	Huestis Compu-Former Summary page 1 …to in CMS' 5 10(k) submission) Varian K943224 (as referred to in CMS' 5 10(k) submission) PAR Scientific K02 1987 Huestis K880047 Intended Use: .decimal tissue compensator/intensity modulator manufacturing service manufactures the solid filte…	Huestis Machine Corp.	1988	—

Also cleared against K000137: 1 other device →

What descends from it? (15)

See all 15

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071078	.Decimal Range Compensator	.Decimal, Inc.	2007	9
K071077	.Decimal Aperture	.Decimal, Inc.	2007	4
K062781	MOD1 Compensators for Radiation Beam Therapy	Symtium Corporation	2006	1
K052383	Innocure Imrt Filter (Compensators)	Innocure, LLC	2006	0

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 4 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K071078 (.Decimal, Inc., 2007) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K000137.

How does its category compare?

All IXI devices

IXI Block, Beam-Shaping, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXI

2in 2022

2007high 3 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXI

90in 2013

2007high 90 (2013) · low 78 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IXI

2in 2013

2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IXI

1in 2016

2007high 28 (2011) · low 0 (2007)2025

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?

.decimal tissue compensator/intensity modulator manufacturing service manufactures

the solid filters for missing tissue and intensity modulation for external beam

radiation therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040804 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040804: .Decimal Tissue Compensator/Intensity Modulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040804

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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