# K060992: Syngo US Workplace

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions
- Decided: Apr 28, 2006 after 17 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K935595 (1995). 47 ancestors in all.
97 later devices descend from it; 2 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052410: Acuson Sequoia Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K051139: Acuson Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K041319: Sequoia Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 1.
- K050034: Sonoline Antares Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K033196: Sonoline Antares with Clarify VE, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K023720: Sonoline Antares Ultrasound System, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K021497: Cypress Ultrasound System, Acuson Corp. (2002) Summary page 1.
- K010950: Cypress System, Acuson Corp. (2001) Summary page 1.
- K891449: Sonoline CF, Siemens Ultrasound, Inc. (1989) Summary page 1.
- K904017: Siemens Sonoline SI-450, OB/Gyn,Ent,Dental Devices, Siemens Ultrasound, Inc. (1991) Summary page 1.
- K052895: Foursight Viewtool Image Viewer, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K022896: CSV12 Software Viewer, Acuson Corp. (2002) Summary page 1.
- K040546: Image-Arena and Research-Arena Applications, Tomtec Imaging Systems GmbH (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K032144: Perifix Catheter Connector, B.Braun Medical, Inc. (2003). Our reading of the summary gave K032144, FDA’s number for Perifix Catheter Connector (B.Braun Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Siemens Ultrasound Systems”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K091286: Syngo US Workplace (2009), 95 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own
- K132165: Qlab Quantification Software (2013), 91 descendants of its own
- K171314: QLAB Advanced Quantification Software (2017), 45 descendants of its own
- K181264: QLAB Advanced Quantification Software (2018), 44 descendants of its own

## Recalls of this device
- Dec 6, 2007 · Not classified · Z-1138-2008: Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.

## Indications for use
syngo® US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.

Source page: https://510kreport.com/device/K060992
Methodology: https://510kreport.com/methodology