# K201062: syngo Ultrasound Apps Suite (sUSAS)

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 18, 2020 after 27 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: 25 generations back to K935595 (1995). 160 ancestors in all.
No later device cites it as a predicate yet.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143254: eSie Apps Suite, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K200585: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2020). Cleared while this submission was under review Summary page 5.

## Indications for use
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens’ CAPs (Clinical Applications Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis. The software supports the following clinical application packages: • eSie Volume Viewer • eSie LVA • eSie PISA • eSie Valves

Source page: https://510kreport.com/device/K201062
Methodology: https://510kreport.com/methodology