# K091286: Syngo US Workplace

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 15, 2009 after 14 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: 11 generations back to K935595 (1995). 66 ancestors in all.
95 later devices descend from it; 3 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060992: Syngo US Workplace, Siemens Medical Solutions (2006) Summary page 1.
- K072090: Siemens Diagnostic Ultrasound Systems, Siemens Medical Solutions USA, Inc., Ultrasound DI (2007) Summary page 1.
- K083149: Arterial Health Package (Ahp) Software, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K172162: ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems (2017), 43 descendants of its own

## 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. The Siemens ultrasound imaging systems are intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

Source page: https://510kreport.com/device/K091286
Methodology: https://510kreport.com/methodology