# K132799: Clariso Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Clariso, Inc.
- Decided: Nov 7, 2013 after 62 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 K954678 (1996). 22 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061421: Erad Pacs, Erad, Inc. (2006) Summary page 1.

## Most influential descendants
- K151957: BOX DICOM Viewer (2015), 3 descendants of its own
- K200822: Braid (2020), 1 descendant of its own
- K231385: Rology Teleradiology Platform (v.1.22.1103) (2023), 0 descendants of its own
- K180549: ZED Link (2018), 0 descendants of its own

## Indications for use
CLARISO PACS is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. CLARISO PACS is used by hospitals, imaging centers, radiologist reading practices. CLARISO PACS is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

Source page: https://510kreport.com/device/K132799
Methodology: https://510kreport.com/methodology