# K051745: Echosystem

- Pathway: 510(k) (Abbreviated)
- Applicant: Medstrat, Inc.
- Decided: Jul 14, 2005 after 15 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: 5 generations back to K896095 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.
- K970064: Amicas Web/Intranet Image Server, Autocyt Group, Inc. (1997) Summary page 1.

## Indications for use
The Medstrat echoeSYSTEMTM is intended to enable the communication, storage, viewing and manipulation of diagnostic medical images and data. The echoeSYSTEMTM can show images on workstations locally and/or across computer networks at widely distributed locations. The echoeSYSTEMTM software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical echoeSYSTEMTM users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and other authorized medical professionals. It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

Source page: https://510kreport.com/device/K051745
Methodology: https://510kreport.com/methodology