# K073418: Syngo Imaging CCF VA10A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Feb 29, 2008 after 86 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011141 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011141: Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-7800TC, Shimadzu Corp. (2001) Summary page 3.
- K071114: Syngo Imaging (Version V30), Siemens AG Medical Solutions (2007) Summary page 3.
- (no number) SIENET MagicWeb (Web Server), MagicLink I: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K073418
Methodology: https://510kreport.com/methodology