# K142514: UniWeb 8.0

- Pathway: 510(k) (Special)
- Applicant: Ebm Technologies Incorporated
- Decided: Dec 18, 2014 after 101 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Full-field digital mammography, MR scanners, CR, ultrasound systems, CT Scanners, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted 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™ 8.0 is utilized only on FDA cleared monitors for interpretation of mammography images in a primary diagnostic setting. Moreover, it can display FFDM(Full-field digital mammography) post-processed images in DICOM for presentation only formats. This device will only use lossless compression or no compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals. However, for image review, the users will not be limited to physicians, nurses and technicians.

Source page: https://510kreport.com/device/K142514
Methodology: https://510kreport.com/methodology