510(k) · Cleared
Clearedsyngo Virtual Cockpit (VB10A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare GmbH · LLZ System, Image Processing, Radiological
Cleared on Dec 21, 2023 as substantially equivalent to K150193 (Ge Medical Systems, LLC, 2015) after a 105-day review. Its family tree reaches back 6 generations to 1997. 4 later devices descend from it.
- Decided
- Dec 21, 2023
- Review
- 105 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K971684 (1997). 29 ancestors in all, the oldest K871859 (1987). 4 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 4 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 2 generations backK061449 Syngo Expert-1Siemens Medical Solution · 2006
- 1 generation backK150193 Customer Remote Console (CRC)Ge Medical Systems, LLC · 2015
- This deviceK232744 syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023
- Descendant · cites it directly · 0 of its ownK243666 uOmniscanShanghai United Imaging Healthcare Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243703 TechLiveDeepHealth, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243333 rTOPRoclub GmbH · 2025
- Descendant · cites it directly · 0 of its ownK242512 ROCC ConsolePhilips Medical Systems Nederland B.V. · 2024
Most influential descendants
Showing 4 of 4 · See all- K243666uOmniscanShanghai United Imaging Healthcare Co., Ltd. · 2025 · cites it directly0descendants
- K243703TechLiveDeepHealth, Inc. · 2025 · cites it directly0descendants
- K243333rTOPRoclub GmbH · 2025 · cites it directly0descendants
- K242512ROCC ConsolePhilips Medical Systems Nederland B.V. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −5 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −4 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −3 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −2 | K061449 | Syngo Expert-1 | Siemens Medical Solution | 2006 | — |
| −1 | K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | 2015 | — |
| 0 (this device) | K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | 2023 | — |
| +1 | K243666 | uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
| +1 | K243703 | TechLive | DeepHealth, Inc. | 2025 | — |
| +1 | K243333 | rTOP | Roclub GmbH | 2025 | — |
| +1 | K242512 | ROCC Console | Philips Medical Systems Nederland B.V. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 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 LLZ? 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 |
|---|---|---|---|
| * | K150193 | Customer Remote Console (CRC)Summary page 4…21CFR § 807.92(a)(3) Predicate Device Device Trade Name Customer Remote Console 510(k) Number K150193 Product Code LLZ This predicate has not been subject to a design-related recall. Reference Device Dev… | 2015 |
| † | K052423 | Magnetom Systems with Syngo Expert - I Option | 2006 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- 13 of the 29 ancestors have a recall of any class.
- Of its descendants, K243666 (Shanghai United Imaging Healthcare Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K150193.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Virtual Cockpit is a software application intended for remote operation, assistance, review, monitoring, and standardization of medical imaging devices. It is a vendor neutral solution allowing read-only or full access control to connected devices. syngo Virtual Cockpit is also intended for training of medical personnel working on the medical imaging devices.
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/K232744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232744: syngo Virtual Cockpit (VB10A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232744
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