# K090649: Vrad Picture Archiving and Communications System Software

- Pathway: 510(k) (Traditional)
- Applicant: Virtual Radiologic Corporation
- Decided: Mar 27, 2009 after 16 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 K033712 (2003). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051553: Fuji Synapse Workstation Software, Fujifilm Medical Systems U.S.A, Inc. (2005) Summary page 1.
- K061672: Synapse Mip/MPR Image Visualization Software Obliquus, Fujifilm Medical Systems U.S.A, Inc. (2006) Summary page 1.

## Most influential descendants
- K092134: Stat Pacs Picture Archiving & Communication System (Pacs) (2009), 1 descendant of its own
- K171130: Nucleus Image Management System (2017), 0 descendants of its own

## Indications for use
The vRadTM PACS software is used with general purpose computing hardware, which meets or exceeds minimum specifications. vRadTM PACS software is intended to receive, transmit, store and display images for clinical purposes. The vRad TM PACS Viewer component is intended for installation on an off-the-shelf PC, meeting or exceeding minimum specifications and networked with vRad Tm PACS Storage component. The vRadTM PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad TM PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities. The vRad TM PACS system should not be used for Mammography primary image diagnosis.

Source page: https://510kreport.com/device/K090649
Methodology: https://510kreport.com/methodology