510(k) · Cleared
ClearedAccuchanger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direx Systems Corp. · IYE Accelerator, Linear, Medical
Cleared on May 5, 2005 as substantially equivalent to K040553 (Direx Systems Corp., 2004) and 2 other predicates after a 146-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 5, 2005
- Review
- 146 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K970586 (1997). 5 ancestors in all, the oldest K912630 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK970586 Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH · 1997 · Recalled
- 2 generations backK021338 AcculeafDirex Systems Corp. · 2003
- 1 generation backK040553 Modification to AcculeafDirex Systems Corp. · 2004
- This deviceK043409 AccuchangerDirex Systems Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970586 | Brainlab Micro Multi-Leaf Collimator | Brainlab Med. Computersysteme GmbH | 1997 | 1 |
| −2 | K021338 | Acculeaf | Direx Systems Corp. | 2003 | — |
| −1 | K040553 | Modification to Acculeaf | Direx Systems Corp. | 2004 | — |
| 0 (this device) | K043409 | Accuchanger | Direx Systems Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 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? (3)
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 |
|---|---|---|---|
| * | K040553 | Modification to Acculeaf | 2004 |
| * | K010065 | Cranial Stereotactic Equipment | 2002 |
| * | K912630 | Xknife Radiosurgery SystemSummary page 1…The predicate devices for substantial equivalence are: 1. AccuLeaf kO4O5S3, DIREX Systems Corp. 2. CranialStereotacticEquipment kOl 0065 Arplay/BrainLab 3. XKnife K912630, Radionics Software Applications, Inc., Performance Standards: No performance standards have been established for such device und… | 1991 |
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 8 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K040553.
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?
AccuChanger is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for the collimation of megavoltage photon beams in conjunction with Stereotactic Radio Surgery (SRS) and Stereotactic Radio Therapy (SRT) treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043409: Accuchanger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043409
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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