510(k) · Cleared
ClearedMSKai
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mskai · QIH Automated Radiological Image Processing Software
Cleared on Dec 16, 2024 as substantially equivalent to K220497 (Smart Soft Healthcare AD, 2022) after a 269-day review. Its family tree reaches back 18 generations to 1997. 5 of the 195 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 16, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K971684 (1997). 194 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 5 of the 195 devices in this family, counting this one, have a Class I recall.
- Root · 18 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 14 generations between
- 3 generations backK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
- 2 generations backK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
- 1 generation backK220497 CoLumboSmart Soft Healthcare AD · 2022
- This deviceK240793 MSKaiMskai · 2024
Show all 18 generations
- Root · 18 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 17 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 16 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 15 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 14 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 13 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 12 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 11 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 10 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 9 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 8 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 7 generations backK133401 Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR…Siemens Medical Solutions USA, Inc. · 2014
- 6 generations backK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
- 5 generations backK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- 4 generations backK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- 3 generations backK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
- 2 generations backK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
- 1 generation backK220497 CoLumboSmart Soft Healthcare AD · 2022
- This deviceK240793 MSKaiMskai · 2024
Class I recalls in this family
- K153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma…6 generations back · 2016
- K121434 Software Syngo MR D13A for the Magnetom Systems…6 generations back · 2012
- K101347 Magnetom Aera; Magnetom Skyra6 generations back · 2010
- K151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit…7 generations back · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −17 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −16 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −15 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −14 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −13 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −12 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −11 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −10 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −9 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −8 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −7 | K133401 | Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −6 | K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | 2015 | — |
| −5 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −4 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −3 | K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −2 | K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −1 | K220497 | CoLumbo | Smart Soft Healthcare AD | 2022 | — |
| 0 (this device) | K240793 | MSKai | Mskai | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 1 |
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.
5 devices in this family have 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 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 |
|---|---|---|---|
| * | K220497 | CoLumboSummary page 5…l: Radiology Classification Name: Medical image management and processing system (21 CFR 892.2050) Product Code: QIH Device Class: Class II 510(k) Number: K220497 (cleared on June 23, 2022) Device Name: AI-Rad Companion Brain MR Manufacturer: Siemens Healthcare GmbH Classification… | 2022 |
| * | — | AI-Rad Companion (Cardiovascular) Named without a submission number | |
| † | K193290 | AI-Rad Companion Brain MR | 2020 |
| † | K193267 | Al-Rad Companion (Musculoskeletal) | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 6 generations back · ◆ in the 2016 ancestors bar of FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 6 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 6 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 7 generations back · ◆ in the 2015 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 45 of the 194 ancestors have a recall of any class; 5 have a Class I recall.
- 3 other devices also cite its predicate K220497.
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?
MSKai is an image identification, post-processing, measurement, and reporting software tool that provides qualitative viewing and quantitative spine measurements from previously-acquired T 2 weighted DICOM lumbar spine Magnetic Resonance Imaging (MRI) images for users' review, evaluation and analysis. It provides the following functionality to assist users in identifying, observing, measuring and reporting measurements: - Anatomy segmentation; - Anatomy…
Read the full statement (203 words)
MSKai is an image identification, post-processing, measurement, and reporting software tool that provides qualitative viewing and quantitative spine measurements from previously-acquired T 2 weighted DICOM lumbar spine Magnetic Resonance Imaging (MRI) images for users' review, evaluation and analysis. It provides the following functionality to assist users in identifying, observing, measuring and reporting measurements:
- Anatomy segmentation;
- Anatomy labeling;
- Anatomy measurement; and
- Export of measurement results to a qualitative and quantitative report for user's evaluation, amendment and authorization
MSKai does not serve as a diagnostic device by providing or recommending any type of medical diagnosis or treatment. MSKai simply provides users the ability to access objective and repeatable identification, segmentation, measurement and reported measurements of the Lumbar spine. The user is responsible for the indications of preferences and settings, confirming the software-generated measurements, and reviewing, confirming and approving draft reports based on their medical training.
The device is intended to be used only by physicians, radiologist, hospitals and other medical institutions. Only T2 weighted DICOM images of MRI acquired from lumbar spine exams of patients aged 18 and above are acceptable input. MSKai does not support DICOM images of patients that are pregnant, have post-operational complications, tumors, infections, or complex hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240793 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240793: MSKai.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240793
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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