510(k) · Cleared
ClearedConformax MMLC VR1
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 15, 1999 as substantially equivalent to K982549 (Radionics, Inc., 1998) after a 51-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Dec 15, 1999
- Review
- 51 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970586 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970586 Brainlab Micro Multi-Leaf CollimatorBrainlab Med. Computersysteme GmbH · 1997 · Recalled
- 1 generation backK982549 Radionics Mini Multi-Leaf Collimator, Model Radionics MMLCRadionics, Inc. · 1998
- This deviceK993594 Conformax MMLC VR1Radionics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK023519 Radionics Varilink 2Radionics, A Division of Tyco Healthcare Group LP · 2003
Most influential descendants
Showing 1 of 1 · See all- K023519Radionics Varilink 2Radionics, A Division of Tyco Healthcare Group LP · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970586 | Brainlab Micro Multi-Leaf Collimator | Brainlab Med. Computersysteme GmbH | 1997 | 1 |
| −1 | K982549 | Radionics Mini Multi-Leaf Collimator, Model Radionics MMLC | Radionics, Inc. | 1998 | — |
| 0 (this device) | K993594 | Conformax MMLC VR1 | Radionics, Inc. | 1999 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K982549 | Radionics Mini Multi-Leaf Collimator, Model Radionics MMLCSummary page 1…emens LINAC, equipped with PrimeView and Lantis. The LINAC was equipped with the Radionics MMLC interface hardware (BCI box). Predicate Device: Radionics MMLC: 510(k) # K982549, dated December 30, 1998. 18 Intended Use: The intended use for the MMLC VRI1 is: The MMLC is intended to assis… | 1998 |
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 |
|---|---|---|---|
| K023519 | Radionics Varilink 2 | 2003 | 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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K023519 (Radionics, A Division of Tyco Healthcare Group LP, 2003) has gone furthest, with 0 descendants of its own.
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 any 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/K993594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993594: Conformax MMLC VR1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993594
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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