510(k) · Cleared
ClearedTopslane DMLC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topslane International, LLC · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Jul 27, 2006 as substantially equivalent to K004022 (Brainlab AG, 2002) and 1 other predicate after a 184-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jul 27, 2006
- Review
- 184 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K004022 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK004022 M3 (Mirco-Multileaf CollimatorBrainlab AG · 2002 · Recalled
- 1 generation backK020860 M3 (Micro-Multileaf Collimator)Brainlab AG · 2002 · Recalled
- This deviceK060187 Topslane DMLCTopslane International, LLC · 2006
- Descendant · cites it directly · 0 of its ownK090802 Tigrt MLC, Tigrt DMLCLinatech, LLC · 2009
Most influential descendants
Showing 1 of 1 · See all- K090802Tigrt MLC, Tigrt DMLCLinatech, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K004022 | M3 (Mirco-Multileaf Collimator | Brainlab AG | 2002 | 2 |
| −1 | K020860 | M3 (Micro-Multileaf Collimator) | Brainlab AG | 2002 | 1 |
| 0 (this device) | K060187 | Topslane DMLC | Topslane International, LLC | 2006 | — |
| +1 | K090802 | Tigrt MLC, Tigrt DMLC | Linatech, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K004022 | M3 (Mirco-Multileaf CollimatorSummary page 1…Jim Marsh, President Telephone: 727-507-8500 Fax: 727-507-9192 2. Predicate Devices m3 (micro-Multi leaf Collimator) (K004022, K020860) Device Classification Name: Therapeutic X-Ray Collimator Regulatory Class: Class II (according to 21… | 2002 |
| * | K020860 | M3 (Micro-Multileaf Collimator)Summary page 1…Marsh, President Telephone: 727-507-8500 Fax: 727-507-9192 2. Predicate Devices m3 (micro-Multi leaf Collimator) (K004022, K020860) Device Classification Name: Therapeutic X-Ray Collimator Regulatory Class: Class II (according to 21 CFR 892.… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090802 | Tigrt MLC, Tigrt DMLC | 2009 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K090802 (Linatech, LLC, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K004022.
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?
TOPSLANE DMLC is a dynamic multileaf collimator designed to be mounted on the
linear accelerator. It is intended to shape the specific fields, either in static or
dynamic mode, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060187: Topslane DMLC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060187
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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