510(k) · Cleared
ClearedSyngo Carbon Clinicals (VA41)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthineers AG · QIH Automated Radiological Image Processing Software
Cleared on Oct 24, 2025 as substantially equivalent to K232856 (Siemens Healthcare GmbH, 2023) after a 203-day review. Its family tree reaches back 16 generations to 1991. 3 of the 187 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 24, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K913770 (1991). 186 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 187 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations between
- 3 generations backK213665 Syngo Carbon Space VA20ASiemens Healthcare GmbH · 2022
- 2 generations backK230561 Syngo Carbon Space VA30ASiemens Healthcare GmbH · 2023
- 1 generation backK232856 Syngo Carbon ClinicalsSiemens Healthcare GmbH · 2023
- This deviceK251059 Syngo Carbon Clinicals (VA41)Siemens Healthineers AG · 2025
Show all 16 generations
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 15 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 14 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 13 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 12 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 11 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 9 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 7 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 6 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 5 generations backK150843 syngo®.via (version VB10A)Siemens AG · 2015
- 4 generations backK191040 syngo.via (Version VB40A)Siemens Healthcare GmbH · 2019
- 3 generations backK213665 Syngo Carbon Space VA20ASiemens Healthcare GmbH · 2022
- 2 generations backK230561 Syngo Carbon Space VA30ASiemens Healthcare GmbH · 2023
- 1 generation backK232856 Syngo Carbon ClinicalsSiemens Healthcare GmbH · 2023
- This deviceK251059 Syngo Carbon Clinicals (VA41)Siemens Healthineers AG · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −15 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −14 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −13 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −12 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −11 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −9 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −7 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −6 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −5 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| −4 | K191040 | syngo.via (Version VB40A) | Siemens Healthcare GmbH | 2019 | — |
| −3 | K213665 | Syngo Carbon Space VA20A | Siemens Healthcare GmbH | 2022 | — |
| −2 | K230561 | Syngo Carbon Space VA30A | Siemens Healthcare GmbH | 2023 | — |
| −1 | K232856 | Syngo Carbon Clinicals | Siemens Healthcare GmbH | 2023 | — |
| 0 (this device) | K251059 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | 2025 | — |
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 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 17 | 0 |
| 2002 | 13 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 11 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 1 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 1 |
| 2011 | 4 | 0 |
| 2012 | 3 | 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.
3 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 23.5 · 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 |
|---|---|---|---|
| * | K232856 | Syngo Carbon ClinicalsSummary page 5…QIH 4. Predicate Device(s): Main Predicate Device Device/Trade Name: Syngo Carbon Clinicals 510(k) Clearance: K232856 Classification Panel: Radiology Devices Classification Number: 21 CFR 892.2050 Classification… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 7 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 9 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 9 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 43 of the 186 ancestors have a recall of any class; 3 have a Class I recall.
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. 2025, 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?
Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.) OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements. The TimeLens provides the means to compare a region of…
Read the full statement (128 words)
Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)
OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements.
The TimeLens provides the means to compare a region of interest between multiple time points.
The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.
An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251059: Syngo Carbon Clinicals (VA41).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251059
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