510(k) · Cleared
ClearedQuality Reports
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun Nuclear Corporation · IYE Accelerator, Linear, Medical
Cleared on Dec 5, 2014 as substantially equivalent to K123230 (Impac Medical Systems, Inc., 2012) and 1 other predicate after a 122-day review. Its family tree reaches back 11 generations to 1996. 5 later devices descend from it.
- Decided
- Dec 5, 2014
- Review
- 122 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K954874 (1996). 47 ancestors in all, the oldest K885054 (1989). 5 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 7 generations between
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 1 generation backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- This deviceK142142 Quality ReportsSun Nuclear Corporation · 2014
- Descendant · cites it directly · 4 of its ownK162468 ClearCheckRadformation · 2016
- Descendant · 2 generations on · 3 of its ownK220583 ClearCheck Model RADCC V2Radformation, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK231185 MapRTVision Rt, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK253962 ClearCheck (RADCC V2.7)Radformation, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK243301 MapRTVision Rt, Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 9 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 8 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 7 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 6 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 5 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 4 generations backK062163 MimviewerMimvista Corp. · 2006
- 3 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 2 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 1 generation backK123230 Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 2012 · Recalled
- This deviceK142142 Quality ReportsSun Nuclear Corporation · 2014
Most influential descendants
Showing 5 of 5 · See all- K162468ClearCheckRadformation · 2016 · cites it directly4descendants
- K220583ClearCheck Model RADCC V2Radformation, Inc. · 2022 · 2 generations on3descendants
- K231185MapRTVision Rt, Ltd. · 2023 · 3 generations on1descendant
- K253962ClearCheck (RADCC V2.7)Radformation, Inc. · 2026 · 3 generations on0descendants
- K243301MapRTVision Rt, Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −10 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −9 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −8 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −7 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −6 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −5 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −4 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −3 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −2 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −1 | K123230 | Mosaiq Oncology Information System | Impac Medical Systems, Inc. | 2012 | 7 |
| 0 (this device) | K142142 | Quality Reports | Sun Nuclear Corporation | 2014 | — |
| +1 | K162468 | ClearCheck | Radformation | 2016 | — |
| +2 | K220583 | ClearCheck Model RADCC V2 | Radformation, Inc. | 2022 | — |
| +3 | K231185 | MapRT | Vision Rt, Ltd. | 2023 | — |
| +3 | K253962 | ClearCheck (RADCC V2.7) | Radformation, Inc. | 2026 | — |
| +4 | K243301 | MapRT | Vision Rt, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K123230 | Mosaiq Oncology Information SystemSummary page 4…code: IYE Predicate Device(s): Model Name: MOSAIQ Release 2.50 Common Name: Oncology Information System 510(k) # K123230 Manufacturer: IMPAC Medical Systems, Inc. Submitted: November 6, 2012… | 2012 |
| * | K120067 | Mosaiq Oncology Information SystemSummary page 5…Page 5-1 Model Name: MOSAIQ Release 2.40 Common Name: Oncology Information System 510(k) # K120067 Manufacturer: IMPAC Medical Systems, Inc. Submitted: January 9, 2012 2 Description and… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162468 | ClearCheck | 2016 | 4 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 10 of the 47 ancestors have a recall of any class.
- Of its descendants, K162468 (Radformation, 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K123230.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142142 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142142: Quality Reports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142142
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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