# K141554: Esie Apps Suite

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 11, 2014 after 30 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: 19 generations back to K935595 (1995). 149 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132062: Esie Apps Suite, Siemens Medical Solutions USA, Inc. (2013) Summary page 1.
- K102017: SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2010) Summary page 1.
- K132654: Acuson SC2000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. Ultrasound Gro (2013) Summary page 1.

## Most influential descendants
- 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 a software-only product to be run on a users PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (clinical application 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

Source page: https://510kreport.com/device/K141554
Methodology: https://510kreport.com/methodology