510(k) · Cleared
ClearedModification to Acculeaf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direx Systems Corp. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Apr 1, 2004 as substantially equivalent to K021338 (Direx Systems Corp., 2003) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Apr 1, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970586 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK970586 Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH · 1997 · Recalled
- 1 generation backK021338 AcculeafDirex Systems Corp. · 2003
- This deviceK040553 Modification to AcculeafDirex Systems Corp. · 2004
- Descendant · cites it directly · 1 of its ownK052705 DART-12Direx Systems Corp. · 2006
- Descendant · cites it directly · 0 of its ownK071701 Trackleaf-10Direx Systems Corp. · 2007
- Descendant · cites it directly · 0 of its ownK043409 AccuchangerDirex Systems Corp. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970586 | Brainlab Micro Multi-Leaf Collimator | Brainlab Med. Computersysteme GmbH | 1997 | 1 |
| −1 | K021338 | Acculeaf | Direx Systems Corp. | 2003 | — |
| 0 (this device) | K040553 | Modification to Acculeaf | Direx Systems Corp. | 2004 | — |
| +1 | K052705 | DART-12 | Direx Systems Corp. | 2006 | — |
| +1 | K071701 | Trackleaf-10 | Direx Systems Corp. | 2007 | — |
| +1 | K043409 | Accuchanger | Direx Systems Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 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? (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 |
|---|---|---|---|
| * | K021338 | AcculeafSummary page 2…while AccuLeaf forms apertures at a set of Gantry angles. Substantial Equivalence: The predicate devices for substantial equivalence are: 1. AccuLeafvl.03 (k021338) 2. BrainLAB MMLC (k970586) 7-4 DEPARTMENT OF HEALTH & HUMAN SE… | 2003 |
| * | K970586 | Brainlab Micro Multi-Leaf CollimatorSummary page 1…iewed by the Radiology Panel. Establishment Registration Number 1224828 Predicate Devices: 1. AccuLeaf vl.03 K(02 1338 cleared on January 07, 2003 2. BrainLAB MMLC (k970586) Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Food, Dru… | 1997 |
What descends from it? (3)
3 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 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K052705 (Direx Systems Corp., 2006) has gone furthest, with 1 descendant of its own.
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.
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?
AccuLeaf 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.
In this application AccuLeaf performs the same function as customized beam shaping blocks, and circular or cut blocks collimators, which have been used for many years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040553: Modification to Acculeaf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040553
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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