# K030363: Org@Nizer, Model Version 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Ebit Sanita, S.P.A.
- Decided: Mar 27, 2003 after 51 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: 3 generations back to K896095 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982862: Radworks Medical Imaging Software with Quality Control Module, Applicare Medical Imaging, B.V. (1998) Summary page 1.

## Indications for use
The Ebit Sanita Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing. processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals,after proper installation on an appropriate hardware platform. This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving, reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value: @Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting; @Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.

Source page: https://510kreport.com/device/K030363
Methodology: https://510kreport.com/methodology