510(k) · Cleared
ClearedCoLumbo C-Spine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Soft Healthcare AD · QIH Automated Radiological Image Processing Software
Cleared on Apr 1, 2026 as substantially equivalent to K241211 (Smart Soft Healthcare, 2024) after a 107-day review. Its family tree reaches back 19 generations to 1997. 5 of the 196 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 1, 2026
- Review
- 107 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K971684 (1997). 195 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 5 of the 196 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 15 generations between
- 3 generations backK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK220497 CoLumboSmart Soft Healthcare AD · 2022
- 1 generation backK241211 CoLumboSmart Soft Healthcare · 2024
- This deviceK254015 CoLumbo C-SpineSmart Soft Healthcare AD · 2026
Show all 19 generations
- Root · 19 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 18 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 17 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 16 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 15 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 14 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 13 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 12 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 11 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 10 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 9 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 8 generations backK133401 Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR…Siemens Medical Solutions USA, Inc. · 2014
- 7 generations backK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
- 6 generations backK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- 5 generations backK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- 4 generations backK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
- 3 generations backK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK220497 CoLumboSmart Soft Healthcare AD · 2022
- 1 generation backK241211 CoLumboSmart Soft Healthcare · 2024
- This deviceK254015 CoLumbo C-SpineSmart Soft Healthcare AD · 2026
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 |
|---|---|---|---|---|---|
| −19 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −18 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −17 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −16 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −15 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −14 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −13 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −12 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −11 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −10 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −9 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −8 | K133401 | Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −7 | K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | 2015 | — |
| −6 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −5 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −4 | K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −3 | K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −2 | K220497 | CoLumbo | Smart Soft Healthcare AD | 2022 | — |
| −1 | K241211 | CoLumbo | Smart Soft Healthcare | 2024 | — |
| 0 (this device) | K254015 | CoLumbo C-Spine | Smart Soft Healthcare AD | 2026 | — |
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? (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 |
|---|---|---|---|
| * | K241211 | CoLumboSummary page 5…: Medical image management and processing system (21 CFR 892.2050) Classification Product Code: QIH Classification Panel: Radiology Device Class: Class II 510(k) Number: K241211 cleared August 15, 2024 4. Device Description CoLumbo C-Spine is a medical device (software) for assisting in the viewing and i… | 2024 |
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 29 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 45 of the 195 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K241211.
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?
CoLumbo C-Spine is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM cervical spine Magnetic Resonance (MR) images for users’ review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements: • Segmentation of the vertebrae (C3-C7) and disks (C2C3-C7T1); • Measurements based on…
Read the full statement (248 words)
CoLumbo C-Spine is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM cervical spine Magnetic Resonance (MR) images for users’ review, analysis, and interpretation. It provides the following functionality to assist users in visualizing, measuring and documenting out-of-range measurements:
• Segmentation of the vertebrae (C3-C7) and disks (C2C3-C7T1);
• Measurements based on the segmentation;
• Threshold-based labeling of out-of-range measurement; and
• Export of measurement results.
CoLumbo C-Spine does not produce or recommend any type of medical diagnosis or treatment. The device outputs are intended to be a starting point for a clinical workflow and should not be interpreted or used as a diagnosis. Instead, CoLumbo C-Spine simply helps users to more easily identify and classify features in cervical MR images and potentially compile a report. The user is responsible for confirming/modifying settings, reviewing the software-generated measurements, utilizing CoLumbo C-Spine's output using their medical judgment and discretion.
The device is intended to be used only by hospitals and other medical institutions.
Only DICOM MR images of the spine of patients aged 22 and above with adequate visualization of C2–C7 are considered to be valid input. Performance has not been established in the presence of vertebral enumeration variants that may interfere with reliable vertebral counting, including true cervical ribs, hemivertebrae, congenital or acquired vertebral fusion, for images acquired with contrast media, for cases involving tumors, infections, post-operative changes, or vertebral fusion, or for examinations in which the C2 vertebra is not adequately visualized.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254015 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254015: CoLumbo C-Spine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254015
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