510(k) · Cleared
ClearedAccuContour
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manteia Technologies Co., Ltd. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Mar 9, 2023 as substantially equivalent to K191928 (Xiamen Manteia Technology, Ltd., 2020) after a 269-day review. Its family tree reaches back 15 generations to 1996. 1 of the 104 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 9, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K954874 (1996). 101 ancestors in all, the oldest K885054 (1989). 2 later devices descend from it, 2 citing it directly. 1 of the 104 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 11 generations between
- 3 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 2 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 1 generation backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- This deviceK221706 AccuContourManteia Technologies Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK251351 AccuContour 4.0Manteia Technologies Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250780 ARTAssistantManteia 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 backK103785 Mobile MimMim Software, Inc. · 2011
- 6 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 5 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 4 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 3 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 2 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 1 generation backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- This deviceK221706 AccuContourManteia Technologies Co., Ltd. · 2023
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…5 generations back · 1999
Most influential descendants
Showing 2 of 2 · See allView 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 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −4 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −3 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −2 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −1 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| 0 (this device) | K221706 | AccuContour | Manteia Technologies Co., Ltd. | 2023 | — |
| +1 | K251351 | AccuContour 4.0 | Manteia Technologies Co., Ltd. | 2026 | — |
| +1 | K250780 | ARTAssistant | Manteia Technologies Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 1 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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 QKB device
- #1 K191928 AccuContourscore 32.8 · 14 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 |
|---|---|---|---|
| * | K191928 | AccuContourSummary page 4…21CFR 892.2050 Review Panel: Radiology Ⅲ. PREDICATE DEVICE Device 510(k) Number Product Name Predicate Device K191928 AccuContourTM Reference Device K182624 MIM-MRT Dosimetry Reference… | 2020 |
| † | K182624 | MIM - MRT Dosimetry | 2018 |
| † | K173636 | Velocity | 2018 |
| † | K181572 | Workflow Box | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 5 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 31 of the 101 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251351 (Manteia Technologies Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K191928.
How does its category compare?
All QKB devicesQKB Radiological Image Processing Software For Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QKB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKB
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QKB
No recall names QKB since 2007.
Adverse event reports per year · QKB
No MAUDE report names QKB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 4 | 244 | 0 | 0 |
| 2021 | 9 | 120 | 0 | 0 |
| 2022 | 7 | 162 | 0 | 0 |
| 2023 | 7 | 111 | 0 | 0 |
| 2024 | 6 | 173 | 0 | 0 |
| 2025 | 6 | 170 | 0 | 0 |
| 2026 | 9 | 179 | 0 | — |
What is it indicated for?
It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221706: AccuContour.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221706
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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