# K060453: Aze Virtualplace

- Pathway: 510(k) (Traditional)
- Applicant: Aze, Ltd.
- Decided: Mar 9, 2006 after 15 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: 5 generations back to K954678 (1996). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052995: Advantage Workstation 4.3., GE Healthcare (2005) Summary page 1.
- K032096: Philips Viewforum 2003, Philips Medical Systems (2003) Summary page 1.
- K051528: Mevis Liveranalyser/Liverviewer Software, Mevis Technology GmbH & Co. KG (2005) Summary page 1.
- K050703: Qbrain, Medis Medical Imaging Systems BV (2005) Summary page 1.
- K052467: Brain Viewrx Viewer, Version 1.0, Kyron Clinical Imaging, Inc. (2005) Summary page 1.

## Most influential descendants
- K133521: Aze Phoenix Software (2014), 0 descendants of its own

## Indications for use
AZE VirtualPlace is an image processing workstation that accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, communication, printing and quantification. When interpreted by a trained physician, filmed or displayed images on the VirtualPlace monitor may be used as a basis for diagnosis, except in the case of mammography images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K060453
Methodology: https://510kreport.com/methodology