510(k) · Cleared
Recalled · 2008Modification to: on-Board Imager Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Aug 4, 2004 as substantially equivalent to K040192 (Varian Medical Systems, Inc., 2004) after a 58-day review. Its family tree reaches back 3 generations to 1996. It has been recalled 2 times.
- Decided
- Aug 4, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963624 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 2 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 1 generation backK040192 ON-Board Imager DeviceVarian Medical Systems, Inc. · 2004 · Recalled
- This deviceK041519 Modification to: on-Board Imager DeviceVarian Medical Systems, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −2 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −1 | K040192 | ON-Board Imager Device | Varian Medical Systems, Inc. | 2004 | 2 |
| 0 (this device) | K041519 | Modification to: on-Board Imager Device | Varian Medical Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K040192 | ON-Board Imager DeviceSummary page 1…Product Code: 90 IYE 3. Predicate Devices to claim substantial equivalence: a. Varian Medical Systems'On Board Imager, K040192 4. Device Description: The present device (K040192) is cleared to make corrections to a patient's position based on a c… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2008 | Not classified | Z-1442-2008 | Software design | If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment. |
| Apr 18, 2007 | Not classified | Z-1195-2007 | Device Design | Patient positioning errors may occur because of mechanical variations during product installation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 3 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K040192.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041519: Modification to: on-Board Imager Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041519
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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