510(k) · Cleared
ClearedDeepXray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha Intelligence Manifolds, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Sep 8, 2023 as substantially equivalent to K192109 (Ib Lab GmbH, 2019) and 1 other predicate after a 277-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Sep 8, 2023
- Review
- 277 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K942948 (1995). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 5 generations between
- 3 generations backK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- 2 generations backK192109 KOALAIb Lab GmbH · 2019
- 1 generation backK203696 RBkneeRadiobotics Aps · 2021
- This deviceK223621 DeepXrayAlpha Intelligence Manifolds, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK253172 MediAI-OACrescom Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 8 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 7 generations backK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
- 6 generations backK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- 5 generations backK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- 4 generations backK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- 3 generations backK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- 2 generations backK192109 KOALAIb Lab GmbH · 2019
- 1 generation backK203696 RBkneeRadiobotics Aps · 2021
- This deviceK223621 DeepXrayAlpha Intelligence Manifolds, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K253172MediAI-OACrescom Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −8 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −7 | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | 4 |
| −6 | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| −5 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| −4 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| −3 | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
| −2 | K192109 | KOALA | Ib Lab GmbH | 2019 | — |
| −1 | K203696 | RBknee | Radiobotics Aps | 2021 | — |
| 0 (this device) | K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | 2023 | — |
| +1 | K253172 | MediAI-OA | Crescom Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K192109 | KOALASummary page 4…logical Image Processing Software Device Class: Class II Review Panel: Radiology Predicate Devices: IB Lab GmbH’s KOALA (K192109) Radiobotics ApS’s RBknee (K203696) Device Description DeepXray is a standalone software device… | 2019 |
| * | K203696 | RBkneeSummary page 4…Class II Review Panel: Radiology Predicate Devices: IB Lab GmbH’s KOALA (K192109) Radiobotics ApS’s RBknee (K203696) Device Description DeepXray is a standalone software device that utilizes artificial intelligence (AI) and computer vision al… | 2021 |
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 |
|---|---|---|---|
| K253172 | MediAI-OA | 2026 | 0 |
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 28 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K253172 (Crescom Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K192109.
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. 2023, 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?
DeepXray is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of…
Read the full statement (115 words)
DeepXray is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee.
It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis.
The system is to be used by trained professionals including, but not limited to, radiologists, orthopedists, physicians and medical technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223621: DeepXray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223621
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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