# K092125: Presidio Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Reaonix Security, LLC
- Decided: Dec 10, 2009 after 148 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: 3 generations back to K002936 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082808: Imagesvr Pacs, Jaguar Technology Limited (2009) Summary page 1.
- K083182: Datacom DC Pacs, Datacom Technology Corp. (2009) Summary page 1.

## Indications for use
The Presidio PACS software 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, Presidio 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. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Source page: https://510kreport.com/device/K092125
Methodology: https://510kreport.com/methodology