# K071166: Uniweb, Version 5.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Electronic Business Machine Co., Ltd. (Ebm)
- Decided: Jul 23, 2007 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
UniWeb TM is a device that receives digital images and data from various sources (including but not limited to digital mammography, MR scanners, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations. UniWeb TM will be used to display FFDM (Full Field Digital Mammography) post-processed images in DICOM for presentation only formats. UniWeb TM will NOT utilize digitized film images, only images from FFDM modalities. UniWebTM will be utilized for interpretation of mammography images in a primary diagnostic setting. UniWebTM will be utilized only on FDA approved monitors used for mammography. Typical users of this device are trained professionals, including but not limited to physicians, nurses and technicians. This product will only use lossless compression or no compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals.

Source page: https://510kreport.com/device/K071166
Methodology: https://510kreport.com/methodology