510(k) · Cleared
ClearedEFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Fortune.Ai, Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Jun 7, 2024 as substantially equivalent to K200356 (Medo.Ai, 2020) after a 169-day review. Its family tree reaches back 18 generations to 1995. 2 later devices descend from it.
- Decided
- Jun 7, 2024
- Review
- 169 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K935595 (1995). 88 ancestors in all, the oldest K891449 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- 2 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 1 generation backK200356 Medo AriaMedo.Ai · 2020
- This deviceK234042 EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK262390 BoneXpertVisiana · 2026
- Descendant · cites it directly · 0 of its ownK250914 MediAI-BACrescom Co., Ltd. · 2025
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 9 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 8 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 7 generations backK091286 Syngo US WorkplaceSiemens Medical Solutions USA, Inc. · 2009
- 6 generations backK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- 5 generations backK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- 4 generations backK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- 3 generations backK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
- 2 generations backK191647 QLAB Advanced Quantification SoftwarePhilips Health Care · 2019
- 1 generation backK200356 Medo AriaMedo.Ai · 2020
- This deviceK234042 EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)Ever Fortune.Ai, Co., Ltd. · 2024
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 |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −9 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −8 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −7 | K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −6 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| −5 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| −4 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| −3 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
| −2 | K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019 | — |
| −1 | K200356 | Medo Aria | Medo.Ai | 2020 | — |
| 0 (this device) | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.Ai, Co., Ltd. | 2024 | — |
| +1 | K262390 | BoneXpert | Visiana | 2026 | — |
| +1 | K250914 | MediAI-BA | Crescom Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 12 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 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.
Planning a device in QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K200356 | Medo AriaSummary page 4…uct Code QIH Regulatory Class II 3. Predicate Device Proprietary Name Medo Aria Premarket Notification K200356 EFAI BAPXR Traditional 510(k) 1 Classification Name… | 2020 |
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? (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 7 companies; a new generation was cleared every 11 months on median.
- 22 of the 88 ancestors have a recall of any class.
- Of its descendants, K262390 (Visiana, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 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 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
EFAI BONESUITE XR BONE AGE PRO ASSESSMENT SYSTEM (EFAI BAPXR) is designed to
view and quantify bone age from 2D Posterior Anterior (PA) view of left-hand radiographs using
deep learning techniques to aid in the analysis of bone age assessment of patients between 2 to 16
years old for pediatric radiologists. The results should not be relied upon alone by pediatric
radiologists to make diagnostic decisions. The images shall be with left hand and wrist fully visible
within the field of view, and shall be without any major bone destruction, deformity, fracture,
excessive motion, or other major artifacts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234042: EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234042
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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