# K023394: Unisight System with Unigate

- Pathway: 510(k) (Abbreviated)
- Applicant: Electronic Business Machine Co., Ltd. (Ebm)
- Decided: Jan 7, 2003 after 90 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
UniSightTM system with UniGateTM is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, 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 computer network at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.

Source page: https://510kreport.com/device/K023394
Methodology: https://510kreport.com/methodology