510(k) · Cleared
Recalled · Class II · 2013APEX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Limited · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Sep 30, 2011 as substantially equivalent to K001163 (3D Line USA, Inc., 2000) after a 107-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Sep 30, 2011
- Review
- 107 days
- Class
- Class II
- Product code
- IXI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001163 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001163 DMLC IV-Ergo3D Line USA, Inc. · 2000 · Recalled
- This deviceK111676 APEXElekta Limited · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001163 | DMLC IV-Ergo | 3D Line USA, Inc. | 2000 | 3 |
| 0 (this device) | K111676 | APEX | Elekta Limited | 2011 | — |
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? (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 |
|---|---|---|---|
| * | K001163 | DMLC IV-ErgoSummary page 1…rade Name: Apex™ | Common Name: Add-on microMLC Classification Name: BLOCK, BEAM-SHAPING, RADIATION THERAPY (21CFR 892 5710, Product Code 1XI) Predicate Device: DMLC IV (K001163) Product Description: This Traditional 510(k) describes medifications made to the add-on DMLC accessory for the Elekta range of… | 2000 |
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 18, 2013 | Class II | Z-0885-2013 | Employee error | If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K001163.
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. 2011, this device’s year, is highlighted.
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?
Apex Is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111676: APEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111676
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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