510(k) · Cleared
ClearedSyngo Carbon Space (VA4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthineers AG · LLZ System, Image Processing, Radiological
Cleared on Sep 29, 2026 as substantially equivalent to K230561 (Siemens Healthcare GmbH, 2023) after a 29-day review. Its family tree reaches back 15 generations to 1991. 3 of the 186 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 29, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K913770 (1991). 185 ancestors in all, the oldest K837107 (1983). No later device cites it as a predicate yet. 3 of the 186 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations between
- 3 generations backK191040 syngo.via (Version VB40A)Siemens Healthcare GmbH · 2019
- 2 generations backK213665 Syngo Carbon Space VA20ASiemens Healthcare GmbH · 2022
- 1 generation backK230561 Syngo Carbon Space VA30ASiemens Healthcare GmbH · 2023
- This deviceK263048 Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
Show all 15 generations
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 14 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 13 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 12 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 11 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 10 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 9 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 8 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 6 generations backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- 5 generations backK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- 4 generations backK150843 syngo®.via (version VB10A)Siemens AG · 2015
- 3 generations backK191040 syngo.via (Version VB40A)Siemens Healthcare GmbH · 2019
- 2 generations backK213665 Syngo Carbon Space VA20ASiemens Healthcare GmbH · 2022
- 1 generation backK230561 Syngo Carbon Space VA30ASiemens Healthcare GmbH · 2023
- This deviceK263048 Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −14 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −13 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −12 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −11 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −10 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −9 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −8 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −6 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| −5 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| −4 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| −3 | K191040 | syngo.via (Version VB40A) | Siemens Healthcare GmbH | 2019 | — |
| −2 | K213665 | Syngo Carbon Space VA20A | Siemens Healthcare GmbH | 2022 | — |
| −1 | K230561 | Syngo Carbon Space VA30A | Siemens Healthcare GmbH | 2023 | — |
| 0 (this device) | K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | 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 | 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K230561 | Syngo Carbon Space VA30ASummary page 6…©Siemens Healthineers AG, 2026 5. Legally Marketed Predicate Device: Device/Trade Name: Syngo Carbon Space (VA30A) 510(k) Clearance: K230561 Common Name: System, Image processing, Radiological Classification Name: Medical Image Mana… | 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 · 6 generations back · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 8 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 43 of the 185 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K230561.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Syngo Carbon Space is indicated for display, rendering, post-processing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine, and Cardiology.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K263048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K263048: Syngo Carbon Space (VA4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K263048
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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