# K980220: Iisys Pacs System

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Diagnostic Imaging, Inc.
- Decided: Feb 13, 1998 after 22 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K984405: Echolive Family, Models: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 (1999), 0 descendants of its own

## Indications for use
The iiSYS PACS System is a complete PACS System for thhe Transmission, Display, Archive, and printing of patient images and demographic information. The system is indicated for the assembly, organization, sharing, and display of patient images and demographic information for diagnostic and referral purposes. Application areas include radiologist central reading rooms or any location where a medical professional would require or desire access to patient image and demographic information.

Source page: https://510kreport.com/device/K980220
Methodology: https://510kreport.com/methodology