510(k) · Cleared
ClearedEFAI RTSuite CT HN-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 Apr 28, 2022 as substantially equivalent to K191928 (Xiamen Manteia Technology, Ltd., 2020) after an 87-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
- Apr 28, 2022
- Review
- 87 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, 1 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 deviceK220264 EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK231928 EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK251306 Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd. · 2026
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 deviceK220264 EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd. · 2022
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) | K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2022 | — |
| +1 | K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 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…ct Code QKB Regulatory Class II 3. Predicate Device Proprietary Name AccuContour Premarket Notification K191928 Classification Name Picture Archiving and Communications System Regulation Number 21 CFR 892.2050… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | 2023 | 1 |
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 26 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, K231928 (Ever Fortune.Ai, Co., Ltd., 2023) has gone furthest, with 1 descendant 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. 2022, 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?
EFATTINSeg 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 in the head and neck region on non-contrast C'1" images. EFAI HNSeg is intended to be used on adult patients only. The contours are generated by…
Read the full statement (150 words)
EFATTINSeg 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 in the head and neck region on non-contrast C'1" images. EFAI
HNSeg 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. EFAT HNSeg must be used in conjunction with a DICOM-compliant treatment planning system to review and
edit results generated. EFAI HNSeg is not intended to be used for decision making or to detect lesions.
EFAI HNSeg 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220264: EFAI RTSuite CT HN-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/K220264
Report an extraction error
Are you the manufacturer?
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