# K082808: Imagesvr Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Jaguar Technology Limited
- Decided: Jan 9, 2009 after 107 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: 2 generations back to K002936 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022710: Smartpacs, Taiwan Electronic Data Processing Corporation (2002) Summary page 1.

## Most influential descendants
- K092125: Presidio Pacs (2009), 0 descendants of its own

## Indications for use
The ImageSVR PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. To support the diagnostic interpretation of mammography studies, ImageSVR PACS will display the full fidelity DICOM' image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.

Source page: https://510kreport.com/device/K082808
Methodology: https://510kreport.com/methodology