510(k) · Cleared
ClearedEFAI RTSUITE CT HCAP-Segmentation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Fortune.Ai, Co., Ltd. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Sep 25, 2023 as substantially equivalent to K220264 (Ever Fortune.Ai, Co., Ltd., 2022) after an 87-day review. Its family tree reaches back 16 generations to 1996. 1 of the 104 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 25, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K954874 (1996). 102 ancestors in all, the oldest K885054 (1989). 1 later device descends from it, 1 citing it directly. 1 of the 104 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 12 generations between
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 1 generation backK220264 EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd. · 2022
- This deviceK231928 EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK251306 Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd. · 2026
Show all 16 generations
- Root · 16 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 15 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 14 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 13 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 12 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 11 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 10 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 9 generations backK062163 MimviewerMimvista Corp. · 2006
- 8 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 7 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 6 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 5 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 4 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 3 generations backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- 2 generations backK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- 1 generation backK220264 EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd. · 2022
- This deviceK231928 EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd. · 2023
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…6 generations back · 1999
Most influential descendants
Showing 1 of 1 · See all- K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −15 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −14 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −13 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −12 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −11 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −10 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −9 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −8 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −7 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −6 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −5 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −4 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| −2 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| −1 | K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
| 0 (this device) | K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2023 | — |
| +1 | K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K220264 | EFAI RTSuite CT HN-Segmentation SystemSummary page 4…QKB Regulatory Class II 3. Predicate Device Proprietary Name EFAI RTSuite CT HN-Segmentation System Premarket Notification K220264 Radiological Image Processing Software For Radiation Classification Name… | 2022 |
| † | K191928 | AccuContour | 2020 |
| † | K220598 | AutoContour Model RADAC V2 | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251306 | Seg Pro V3 (RT-300) | 2026 | 0 |
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 · 6 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 102 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K251306 (Ever Fortune.Ai, Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
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?
EFAI HCAPSeg is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk on non-contrast CT images. EFAI HCAPSeg is intended to be used on adult patients only. The contours are generated by deep-learning algorithms and then…
Read the full statement (145 words)
EFAI HCAPSeg is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk on non-contrast CT images. EFAI HCAPSeg is intended to be used on adult patients only.
The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. EFAI HCAPSeg must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. EFAI HCAPSeg is not intended to be used for decision making or to detect lesions.
EFAI HCAPSeg is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on CT. Clinicians must not use the software generated output alone without review as the primary interpretation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231928: EFAI RTSUITE CT HCAP-Segmentation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231928
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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