# K070796: Chili Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Chili GmbH
- Decided: Apr 6, 2007 after 14 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 K924178 (1993). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052461: Syngo Imaging Version V20A, Siemens AG Medical Solutions (2005) Summary page 1.

## Indications for use
The CHILI PACS is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e. * Displaying * Processing * Reading * Reporting * Communicating / distributing * Storing / archiving of radiological softcopy images and * Storing / archiving of structured (DICOM) reports, The system is a 'software only" solution and is intended to assist the physician in diagnosis or treatment planning (excluding screening and primary diagnosis of mammography images). Therefore CHILI PACS supports the following generic imaging workflow: * Receive scheduled exams from ISat the CHILI PACS archiving component CHILI Server * Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces * Receive and store new exams from the Modalities at the CHILI Server * Prepare images for reading * Report new images, if required by comparing them with prior exams and reports * Demonstrate exams at Radiological Demos * View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians). Note: The workstation deployment CHILI 3D-Plugln is not intended for primary diagnosis.

Source page: https://510kreport.com/device/K070796
Methodology: https://510kreport.com/methodology