# K162145: vRad PACS with Mammography

- Pathway: 510(k) (Abbreviated)
- Applicant: Virtual Radiologic Corporation
- Decided: Oct 25, 2016 after 85 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K051553 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112439: Synapse Workstation Software Version 3.3.0, Fujifilm Medical System U.S.A., Inc. (2011) Summary page 4.

## Most influential descendants
- K241879: vRad Viewer (2024), 0 descendants of its own

## Recalls of this device
- May 9, 2023 · Class II · Z-2235-2023: The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.

## Indications for use
The vRad PACS with Mammography software is used with general purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with vRad PACS Storage component. The vRad 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 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 Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer. vRad PACS with Mammography may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and displayed on a monitor that meets technical specifications reviewed and cleared by FDA.

Source page: https://510kreport.com/device/K162145
Methodology: https://510kreport.com/methodology