510(k) · Cleared
ClearedSyngo Imaging CCF VA10A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · LLZ System, Image Processing, Radiological
Cleared on Feb 29, 2008 as substantially equivalent to K011141 (Shimadzu Corp., 2001) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Feb 29, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011141 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK011141 Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TCShimadzu Corp. · 2001
- This deviceK073418 Syngo Imaging CCF VA10ASiemens AG Medical Solutions · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011141 | Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TC | Shimadzu Corp. | 2001 | — |
| 0 (this device) | K073418 | Syngo Imaging CCF VA10A | Siemens AG Medical Solutions | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K011141 | Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TCSummary page 3…tantially equivalent to the following commercially available devices: Siemens syngoImaging - - - Fly~~~~~~~~~g, K011141 K071114 Siemens S1ENET MagicWeb (Web Server), MagicLink I The syngo® Imaging CCFVA1OA described… | 2001 |
| * | K071114 | Syngo Imaging (Version V30)Summary page 3…to the following commercially available devices: Siemens syngoImaging - - - Fly~~~~~~~~~g, K011141 K071114 Siemens S1ENET MagicWeb (Web Server), MagicLink I The syngo® Imaging CCFVA1OA described in this 510(k) has… | 2007 |
| * | — | SIENET MagicWeb (Web Server), MagicLink I Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Imaging CCF is a Picture Archiving and Communication System intended for enterprise wide storage, archiving and distribution of digital radiology images and reports to clinical personnel for viewing of current and prior studies. It is not intended for primary diagnosis. It offers the possibility to store the images in uncompressed/lossless compressed and lossy compressed format depending on modality specific configuration to optimize usage of…
Read the full statement (114 words)
syngo Imaging CCF is a Picture Archiving and Communication System intended for enterprise wide storage, archiving and distribution of digital radiology images and reports to clinical personnel for viewing of current and prior studies. It is not intended for primary diagnosis.
It offers the possibility to store the images in uncompressed/lossless compressed and lossy compressed format depending on modality specific configuration to optimize usage of storage space.
All lossy compressed images are displayed with warning triangles to indicate that the images are not suitable for diagnosis. In DICOM transfers, the respective compression related DICOM attributes are filled.
In a comprehensive imaging suite, syngo Imaging integrates hospital information systems (HIS) to enable customer specific workflows.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073418: Syngo Imaging CCF VA10A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073418
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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