510(k) · Cleared
ClearedSyngo Expert-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solution · JAK System, X-Ray, Tomography, Computed
Cleared on Jul 25, 2006 as substantially equivalent to K052423 (Siemens Medi Cal Solutions, Inc., 2006) after a 61-day review. Its family tree reaches back 4 generations to 1997. 13 later devices descend from it.
- Decided
- Jul 25, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971684 (1997). 10 ancestors in all, the oldest K970852 (1997). 13 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 1 generation backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- This deviceK061449 Syngo Expert-1Siemens Medical Solution · 2006
- Descendant · cites it directly · 12 of its ownK150193 Customer Remote Console (CRC)Ge Medical Systems, LLC · 2015
- Descendant · 2 generations on · 4 of its ownK232744 syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023
- Descendant · 2 generations on · 4 of its ownK200179 Collaboration LivePhilips Health Care · 2020
- Descendant · 3 generations on · 2 of its ownK201665 Collaboration LivePhilips Ultrasound, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK212777 Collaboration LivePhilips Ultrasound, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K150193Customer Remote Console (CRC)Ge Medical Systems, LLC · 2015 · cites it directly12descendants
- K232744syngo Virtual Cockpit (VB10A)Siemens Healthcare GmbH · 2023 · 2 generations on4descendants
- K200179Collaboration LivePhilips Health Care · 2020 · 2 generations on4descendants
- K201665Collaboration LivePhilips Ultrasound, Inc. · 2020 · 3 generations on2descendants
- K212777Collaboration LivePhilips Ultrasound, Inc. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −3 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −2 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −1 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| 0 (this device) | K061449 | Syngo Expert-1 | Siemens Medical Solution | 2006 | — |
| +1 | K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | 2015 | — |
| +2 | K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | 2023 | — |
| +2 | K200179 | Collaboration Live | Philips Health Care | 2020 | — |
| +3 | K201665 | Collaboration Live | Philips Ultrasound, Inc. | 2020 | — |
| +4 | K212777 | Collaboration Live | Philips Ultrasound, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K052423 | Magnetom Systems with Syngo Expert - I OptionSummary page 1…ommercial distribution: Predicate Device Name FDA Clearance Number FDA Clearance Date syngo Expert-I K052423 01/13/2006 Siemens Medical Solutions, Inc. USA Page… | 2006 |
What descends from it? (13)
See all 132 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 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 10 ancestors have a recall of any class.
- Of its descendants, K150193 (Ge Medical Systems, LLC, 2015) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K052423.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The syngo Expert-I option for all Siemens CT systems is intended to allow a remote access to the syngo CT workplace from clients inside the local area network.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061449: Syngo Expert-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061449
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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