# K024159: Strykerware System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Mar 10, 2003 after 83 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: 3 generations back to K924178 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994228: Remoteimage System, Etrauma.Com Corp. (2000) Summary page 1.
- K970064: Amicas Web/Intranet Image Server, Autocyt Group, Inc. (1997) Summary page 1.

## Indications for use
The StrykerwareTM PACS System is a system designed to provide licensed medical professionals access to medical images. This product is intended to be used for reviewing and storing images from a variety of modalities. StrykerWareTM is the system with software installed on a computer configured with connections to image acquisition devices, image storage locations and the internet. The system facilitates the transferal of images between local and remote locations (including but not limited to a licensed medical professional’s operating suite). The users of StrykerwareTM are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

Source page: https://510kreport.com/device/K024159
Methodology: https://510kreport.com/methodology