# K132062: Esie Apps Suite

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 23, 2013 after 20 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: 17 generations back to K935595 (1995). 146 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052895: Foursight Viewtool Image Viewer, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K123622: Acuson, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.

## Most influential descendants
- K141554: Esie Apps Suite (2014), 2 descendants of its own
- K143254: eSie Apps Suite (2014), 1 descendant of its own
- K201062: syngo Ultrasound Apps Suite (sUSAS) (2020), 0 descendants of its own

## Indications for use
eSie Apps Suite software is intended for use as a PACS plug in utilizing the third party application launching feature of the PACS workstation. eSie Apps Suite software will provide the ability to launch Siemens CAPs (Clinical Application Packages) for image processing. Use of a CAP by a qualified clinician can add information to the study to be used for a clinical diagnosis. This initial release employs one CAP, the eSie Volume Viewer, which provides offline viewing and manipulation of the Acuson SC2000 system volume datasets. The typical ultrasound user must be knowledgeable in the use of the ultrasound system in order to properly optimize and utilize the software. The eSie Apps Suite software is intended for use on a PACS workstation that must meet minimum system requirements to run optimally and also supports launching of third party applications.

Source page: https://510kreport.com/device/K132062
Methodology: https://510kreport.com/methodology