510(k) · Cleared
ClearedMediAI-OA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crescom Co., Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Jun 15, 2026 as substantially equivalent to K223621 (Alpha Intelligence Manifolds, Inc., 2023) after a 262-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Jun 15, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K942948 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 6 generations between
- 3 generations backK192109 KOALAIb Lab GmbH · 2019
- 2 generations backK203696 RBkneeRadiobotics Aps · 2021
- 1 generation backK223621 DeepXrayAlpha Intelligence Manifolds, Inc. · 2023
- This deviceK253172 MediAI-OACrescom Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 9 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 8 generations backK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
- 7 generations backK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- 6 generations backK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- 5 generations backK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- 4 generations backK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- 3 generations backK192109 KOALAIb Lab GmbH · 2019
- 2 generations backK203696 RBkneeRadiobotics Aps · 2021
- 1 generation backK223621 DeepXrayAlpha Intelligence Manifolds, Inc. · 2023
- This deviceK253172 MediAI-OACrescom Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −9 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −8 | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | 4 |
| −7 | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| −6 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| −5 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| −4 | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
| −3 | K192109 | KOALA | Ib Lab GmbH | 2019 | — |
| −2 | K203696 | RBknee | Radiobotics Aps | 2021 | — |
| −1 | K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K223621 | DeepXraySummary page 5…Manufacturer: Alpha Intelligence Manifolds, Inc. Device(Trade) Name: DeepXray 510(k) Number: K223621 Regulation Name: Medical image management and processing system… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 13 ancestors have a recall of any class.
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. 2026, 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?
MediAI-OA 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 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.…
Read the full statement (108 words)
MediAI-OA 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 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/K253172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253172: MediAI-OA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253172
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026