# K181318: Onis-Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Digitalcore Co., Ltd.
- Decided: Aug 13, 2018 after 87 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: 6 generations back to K942120 (1994). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062488: IQ-System Pacs System, Image Information Systems, Ltd. (2006) Summary page 4.

## Most influential descendants
- K261874: Syneris PACS v.1.0.1.0 (2026), 0 descendants of its own

## Indications for use
ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing, reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for primary diagnosis or interpretation.

Source page: https://510kreport.com/device/K181318
Methodology: https://510kreport.com/methodology