# K090481: Demasq Imaging Spftware Device

- Pathway: 510(k) (Traditional)
- Applicant: Demasq Limited
- Decided: Mar 19, 2009 after 23 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 K896095 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052545: Infinitt G3 Pacs, Infinitt Co., Ltd. (2005) Summary page 1.
- K071894: Xebra Dicom Image Browser, Hx Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- K092328: Med-Seg, Model BTMS 1000 (2010), 0 descendants of its own

## Indications for use
DEMASQ Imaging Software DeviceTM is a software device that receives medical images and data from various imaging sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. 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. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K090481
Methodology: https://510kreport.com/methodology