510(k) · Cleared
ClearedMicromlc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IXI Block, Beam-Shaping, Radiation Therapy
Cleared on Oct 2, 2003 as substantially equivalent to K000349 (Stryker Leibinger, 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Oct 2, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- IXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000349 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000349 Motorized Micro Multileaf CollimatorStryker Leibinger · 2000
- This deviceK032790 MicromlcSiemens Medical Solutions USA, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000349 | Motorized Micro Multileaf Collimator | Stryker Leibinger | 2000 | — |
| 0 (this device) | K032790 | Micromlc | Siemens Medical Solutions USA, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K000349 | Motorized Micro Multileaf CollimatorSummary page 1…Class II device Product Code: 1x1 Substantial Equivalence Claimed To: Motorized Micro Multileaf Collimator (K000349) Description: The microMLC is a conformal radiation therapy and radiosurgery device that is mounted to a standard ra… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K000349.
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?
The microMLC is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The microMLC is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to assist the clinician in the delivery of well-defined target volumes of radiation while…
Read the full statement (111 words)
The microMLC is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The microMLC is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to assist the clinician in the delivery of well-defined target volumes of radiation while sparing the surrounding tissues and organs.
The Siemens Medical Solutions Oncology Care Systems, microMLC. is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032790: Micromlc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032790
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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