510(k) · Cleared
ClearedMLC Fit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impac Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Mar 27, 2000 as substantially equivalent to K962335 (Impac Medical Systems, Inc., 1997) after a 360-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.
- Decided
- Mar 27, 2000
- Review
- 360 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962335 (1997). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK962335 MLC FitImpac Medical Systems, Inc. · 1997
- This deviceK991133 MLC FitImpac Medical Systems, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK120067 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK142142 Quality ReportsSun Nuclear Corporation · 2014
- Descendant · 3 generations on · 4 of its ownK162468 ClearCheckRadformation · 2016
- Descendant · 4 generations on · 3 of its ownK220583 ClearCheck Model RADCC V2Radformation, Inc. · 2022
- Descendant · 5 generations on · 1 of its ownK231185 MapRTVision Rt, Ltd. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · cites it directly8descendants
- K142142Quality ReportsSun Nuclear Corporation · 2014 · 2 generations on5descendants
- K162468ClearCheckRadformation · 2016 · 3 generations on4descendants
- K220583ClearCheck Model RADCC V2Radformation, Inc. · 2022 · 4 generations on3descendants
- K231185MapRTVision Rt, Ltd. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962335 | MLC Fit | Impac Medical Systems, Inc. | 1997 | — |
| 0 (this device) | K991133 | MLC Fit | Impac Medical Systems, Inc. | 2000 | — |
| +1 | K120067 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 3 |
| +2 | K142142 | Quality Reports | Sun Nuclear Corporation | 2014 | — |
| +3 | K162468 | ClearCheck | Radformation | 2016 | — |
| +4 | K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022 | — |
| +5 | K231185 | MapRT | Vision Rt, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K962335 | MLC FitSummary page 1…vides the definition of the treatment field as a hardcopy and to a database file. The primary functions of MLC Fit are, in effect, the same as those of MLC Fit product (K962335) currently being marketed by IMPAC Medical Systems, Inc. (see Exhibit 3b). Both systems supplement the MLC treatment field defini… | 1997 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120067 | Mosaiq Oncology Information System | 2012 | 8 |
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.
- Of its descendants, K120067 (Impac Medical Systems, Inc., 2012) has gone furthest, with 8 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?
MLC Fit is to be used to define leaf plans for use with radiation treatment machines equipped with multileaf collimators manufactured by Siemens Medical Systems, Varian Associates, and Elekta Oncology Systems, Inc. This method of defining the geometric parameters associated with treatment fields can be used whenever a conformal treatment field is desired.
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/K991133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991133: MLC Fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991133
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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