510(k) Report

510(k) · Cleared

Recalled · 2009

Brainlab Micro Multi-Leaf Collimator

K970586510(k) TraditionalCleared May 12, 199787-day reviewClass II21 CFR 892.5050Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Brainlab Med. Computersysteme GmbH · IYE Accelerator, Linear, Medical

Cleared on May 12, 1997 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 79 later devices descend from it. It has been recalled once.

Decided
May 12, 1997
Review
87 days
Class
Class II
Product code
IYE
Recalls
1
Predicates
0

79 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared1997: 1 descendant cleared2004: 1 descendant cleared1998: 1 descendant cleared2007: 2 descendants cleared2005: 3 descendants cleared2006: 1 descendant cleared1999: 2 descendants cleared2009: 2 descendants cleared2014: 3 descendants cleared2012: 2 descendants cleared2011: 2 descendants cleared2015: 4 descendants cleared2017: 7 descendants cleared2018: 6 descendants cleared2013: 2 descendants cleared2019: 5 descendants cleared2016: 2 descendants cleared2022: 4 descendants cleared2021: 7 descendants cleared2026: 5 descendants cleared2023: 9 descendants cleared2025: 2 descendants cleared2020: 2 descendants cleared2024: 2 descendants cleared1995200020052010201520202025
  1. This deviceK970586 Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH · 1997
  2. Descendant · cites it directly · 70 of its ownK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
  3. Descendant · 2 generations on · 69 of its ownK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
  4. Descendant · 3 generations on · 67 of its ownK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
  5. Descendant · 4 generations on · 64 of its ownK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
  6. Descendant · 4 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 22003: 22004: 12005: 32006: 12007: 22009: 22011: 22012: 22013: 22014: 32015: 42016: 22017: 72018: 62019: 52020: 22021: 72022: 42023: 92024: 22025: 22026: 5
1997high 9 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 79 · See all
  • K973889Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997 · cites it directly70descendants
  • K990085Millennium MLC -120Varian Assoc., Inc. · 1999 · 2 generations on69descendants
  • K050442Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · 3 generations on67descendants
  • K071992High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · 4 generations on64descendants
  • K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 4 generations on61descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970586Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH1997—
+1K973889Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc.1997—
+2K990085Millennium MLC -120Varian Assoc., Inc.19992
+3K050442Millennium Multi-Leaf CollimatorVarian Medical Systems20052
+4K071992High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems20074
+4K092871Trilogy MXVarian Medical Systems, Inc.20095

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199920
200320
200410
200530
200610
200720
200920
201120
201220
201320
201430
201540
201620
201770
201860
201950
202020
202170
202240
202390
202420
202520
202650
FIG. 1 — Lineage of K970586, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (79)

See all 79

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973889Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc.199770
K021338AcculeafDirex Systems Corp.20034
K040553Modification to AcculeafDirex Systems Corp.20043
K982549Radionics Mini Multi-Leaf Collimator, Model Radionics MMLCRadionics, Inc.19982

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 19, 2009Not classifiedZ-1544-2009OtherThe Integrated Multileaf-Collimator (MLC) of the linear accelerator could interfere with the intended conformal fields of the BrainLab m3 micro-Multileaf-Collimator (mMLC) during patient treatment.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K973889 (Varian Medical Systems, Inc., 1997) has gone furthest, with 70 descendants of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

More from Brainlab Med. Computersysteme GmbH

5 FDA decisions under this applicant name. See the company

  • K954861Brainlab CT/X-Ray LocalizerBrainlab Med. Computersysteme GmbH · 1996
  • K952390Brainlab Sterotatic HeadringBrainlab Med. Computersysteme GmbH · 1996
  • K945903Brainlab Mask SystemBrainlab Med. Computersysteme GmbH · 1995
  • K934657Brainlab Linac HardwareBrainlab Med. Computersysteme GmbH · 1994

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The IYE category page

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  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K970586 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970586: Brainlab Micro Multi-Leaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970586

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026