# K092134: Stat Pacs Picture Archiving & Communication System (Pacs)

- Pathway: 510(k) (Traditional)
- Applicant: Statrad, LLC
- Decided: Sep 15, 2009 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: 6 generations back to K945188 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090649: Vrad Picture Archiving and Communications System Software, Virtual Radiologic Corporation (2009) Summary page 1.
- K062490: Visage Pacs/CS, Release Version 4.1, Mercury Computer Systems, Inc. (2006) Summary page 1.
- K082269: Visage Pacs, Version 6.0/CS 3.1, Visage Imaging, Inc. (2008) Summary page 1.

## Most influential descendants
- K171130: Nucleus Image Management System (2017), 0 descendants of its own

## Indications for use
The StatPacsTM is a software based PACS product intended to be used by radiologists, technologists and clinicians, to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospital and remote site use. The StatPacsTM software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis by way of industry standard networked gateways including VPNs, and LAN/WAN through DICOM allowing StatPacsTM to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatViewTM with the Exam ManagerTM application, is a primary user interface for processing of medical images for primary image diagnosis. Image compression and encryption adhere to standard industry protocol. StatPacsTM, is not to be used for mammography imaging.

Source page: https://510kreport.com/device/K092134
Methodology: https://510kreport.com/methodology