510(k) · Cleared
ClearedAccuCheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manteia Technologies Co., Ltd. · IYE Accelerator, Linear, Medical
Cleared on Oct 24, 2025 as substantially equivalent to K223834 (Manteia Technologies Co., Ltd., 2023) after a 231-day review. Its family tree reaches back 15 generations to 1996.
- Decided
- Oct 24, 2025
- Review
- 231 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K954874 (1996). 80 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations between
- 3 generations backK192424 Mobius3DVarian Medical Systems, Inc. · 2019
- 2 generations backK203669 Mobius3DVarian Medical Systems, Inc. · 2021
- 1 generation backK223834 AccuCheckManteia Technologies Co., Ltd. · 2023
- This deviceK250696 AccuCheckManteia Technologies Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 14 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 13 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 12 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 11 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 10 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 9 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 8 generations backK062163 MimviewerMimvista Corp. · 2006
- 7 generations backK070248 VelocityaisVelocity Medical Solutions, LLC · 2007
- 6 generations backK081076 Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC · 2008 · Recalled
- 5 generations backK153014 Mobius3DMobius Medical Systems, LP · 2016
- 4 generations backK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- 3 generations backK192424 Mobius3DVarian Medical Systems, Inc. · 2019
- 2 generations backK203669 Mobius3DVarian Medical Systems, Inc. · 2021
- 1 generation backK223834 AccuCheckManteia Technologies Co., Ltd. · 2023
- This deviceK250696 AccuCheckManteia Technologies Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −14 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −13 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −12 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −11 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −10 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −9 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −8 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −7 | K070248 | Velocityais | Velocity Medical Solutions, LLC | 2007 | — |
| −6 | K081076 | Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response | Velocity Medical Solutions, LLC | 2008 | 1 |
| −5 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| −4 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| −3 | K192424 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| −2 | K203669 | Mobius3D | Varian Medical Systems, Inc. | 2021 | — |
| −1 | K223834 | AccuCheck | Manteia Technologies Co., Ltd. | 2023 | — |
| 0 (this device) | K250696 | AccuCheck | Manteia Technologies Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K223834 | AccuCheckSummary page 5…ct Code: IYE Regulation Number: 21 CFR 892.5050 Review Panel: Radiology III. PREDICATE DEVICE Predicate Device: AccuCheck 1.1 (K223834) IV. DEVICE DESCRIPTION AccuCheck, defined as a radiotherapy plan quality assurance system, aims to improve… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 17 of the 80 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
AccuCheck is a quality assurance software to the quality assurance of general offline planning, online adaptive planning and various radiotherapy technology such as photon and proton. It is used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on Accelerator delivery log after radiotherapy plan execution.
AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
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/K250696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250696: AccuCheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250696
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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