510(k) · Cleared
ClearedLinac Collimator Assembly Housing (Lcah) Model Lcahart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Radionics, Inc. · IYE Accelerator, Linear, Medical
Cleared on Apr 22, 2010 as substantially equivalent to K912630 (Rsa, Inc., 1991) and 1 other predicate after a 99-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Apr 22, 2010
- Review
- 99 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K914698 (1992). 31 ancestors in all, the oldest K862339 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 5 generations between
- 3 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK100096 Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc. · 2010
Show all 9 generations
- Root · 9 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 8 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 7 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 6 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 5 generations backK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK022036 Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc. · 2002
- 3 generations backK031764 Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK060226 Oncor ExpressionSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK072485 Artiste MV SASiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK100096 Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −8 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −7 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −6 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −5 | K013112 | Focal Sim | Computerized Medical Systems, Inc. | 2001 | 10 |
| −4 | K022036 | Siemens Virtual Simulation (Vsim) | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K031764 | Oncor Avant-Garde with Coherence Workspaces | Siemens Medical Solutions USA, Inc. | 2003 | 17 |
| −2 | K060226 | Oncor Expression | Siemens Medical Solutions USA, Inc. | 2006 | 72 |
| −1 | K072485 | Artiste MV SA | Siemens Medical Solutions USA, Inc. | 2007 | 24 |
| 0 (this device) | K100096 | Linac Collimator Assembly Housing (Lcah) Model Lcahart | Integra Radionics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K912630 | Xknife Radiosurgery SystemSummary page 1…IYE Substantial Equivalence: The Linac Collimator Assembly Housing (LCAH) is substantially equivalent in function and intended use with the XKnife Radiosurgery System (K912630) and the ARTISTE MV SA (K072485). Indications Use: The Integra RadioniCSTm Linac Collimator Assembly Housing (LCAH) is intended… | 1991 |
| * | K072485 | Artiste MV SASummary page 1…he Linac Collimator Assembly Housing (LCAH) is substantially equivalent in function and intended use with the XKnife Radiosurgery System (K912630) and the ARTISTE MV SA (K072485). Indications Use: The Integra RadioniCSTm Linac Collimator Assembly Housing (LCAH) is intended to be mounted as an Accessory tr… | 2007 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 13 of the 31 ancestors have a recall of any class.
- 4 other devices also cite its predicate K912630.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Integra Radian iCSTm Linac Collimator Assembly Housing (LOAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Holder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radibsurgery (SRS) and radiotherapy (SRT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100096: Linac Collimator Assembly Housing (Lcah) Model Lcahart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100096
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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