510(k) · Cleared
ClearedRadionics Mini Multi-Leaf Collimator, Model Radionics MMLC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics, Inc. · IYE Accelerator, Linear, Medical
Cleared on Dec 30, 1998 as substantially equivalent to K970586 (Brainlab Med. Computersysteme GmbH, 1997) after a 162-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Dec 30, 1998
- Review
- 162 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970586 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK970586 Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH · 1997 · Recalled
- This deviceK982549 Radionics Mini Multi-Leaf Collimator, Model Radionics MMLCRadionics, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK993594 Conformax MMLC VR1Radionics, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK023519 Radionics Varilink 2Radionics, A Division of Tyco Healthcare Group LP · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970586 | Brainlab Micro Multi-Leaf Collimator | Brainlab Med. Computersysteme GmbH | 1997 | 1 |
| 0 (this device) | K982549 | Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC | Radionics, Inc. | 1998 | — |
| +1 | K993594 | Conformax MMLC VR1 | Radionics, Inc. | 1999 | — |
| +2 | K023519 | Radionics Varilink 2 | Radionics, A Division of Tyco Healthcare Group LP | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 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 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 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K970586 | Brainlab Micro Multi-Leaf CollimatorSummary page 2…3 FDA Establishment Registration No.: 1219140 .Sterilization Site: No part of this device is supplied sterile. Predicate Devices Brainlab Micro Multi-Leaf Collimator (K970586) manufactured by Brainlab Medical Computersysteme GmbH (hereafter referred to as "Brainlab MLC") Page 2 Model MM… | 1997 |
| † | K972905 | XPLAN-1 | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993594 | Conformax MMLC VR1 | 1999 | 1 |
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?
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics XPlan Conformal Treatment Planning Software or treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.
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/K982549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982549: Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982549
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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