510(k) · Cleared
ClearedPerfraction
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 Sep 26, 2014 as substantially equivalent to K072374 (Scanditronix Wellhofer GmbH, 2007) after an 85-day review. Its family tree reaches back 4 generations to 1992. 5 later devices descend from it.
- Decided
- Sep 26, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914698 (1992). 12 ancestors in all, the oldest K874893 (1988). 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 3 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 2 generations backK012227 Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc. · 2001
- 1 generation backK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- This deviceK141800 PerfractionSun Nuclear Corporation · 2014
- Descendant · cites it directly · 1 of its ownK170307 SunCHECKSun Nuclear Corporation · 2017
- Descendant · cites it directly · 0 of its ownK252258 Veriqa RT Epid 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2026
- Descendant · 2 generations on · 0 of its ownK213370 VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK172534 LINACwatch, LinacViewQualiformed Sarl · 2017
- Descendant · cites it directly · 0 of its ownK152994 AdaptivoAurora Technology Development, LLC · 2016
Most influential descendants
Showing 5 of 5 · See all- K170307SunCHECKSun Nuclear Corporation · 2017 · cites it directly1descendant
- K252258Veriqa RT Epid 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2026 · cites it directly0descendants
- K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten · 2022 · 2 generations on0descendants
- K172534LINACwatch, LinacViewQualiformed Sarl · 2017 · cites it directly0descendants
- K152994AdaptivoAurora Technology Development, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −3 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −2 | K012227 | Mucheck - Monitor Unit Validation Program, Model V4.1 | Oncology Data Systems, Inc. | 2001 | — |
| −1 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| 0 (this device) | K141800 | Perfraction | Sun Nuclear Corporation | 2014 | — |
| +1 | K170307 | SunCHECK | Sun Nuclear Corporation | 2017 | — |
| +1 | K252258 | Veriqa RT Epid 3D | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2026 | — |
| +2 | K213370 | Veriqa | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2022 | 2 |
| +1 | K172534 | LINACwatch, LinacView | Qualiformed Sarl | 2017 | — |
| +1 | K152994 | Adaptivo | Aurora Technology Development, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K072374 | CompassSummary page 4…Product code: IYE Predicate Device: Model Name: COMPASS Common Name: Accelerator, linear, medical 510(k) # K072374 Manufacturer: Scanditronix Wellhdfer GmbH Cleared: Dec 7, 2007… | 2007 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K170307 (Sun Nuclear Corporation, 2017) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K072374.
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?
PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient’s radiation therapy treatment.
PerFRACTION allows for the comparison of the cumulative exit image(s) for one treatment fraction to the cumulative exit image(s) for another treatment fraction, thus providing a consistency check on the delivery of the treatment fraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141800: Perfraction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141800
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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