# K231041: JiveX (Model Number / Release: 5.4)

- Pathway: 510(k) (Traditional)
- Applicant: Visus Health IT GmbH
- Decided: Jul 14, 2023 after 93 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: 14 generations back to K971684 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212321: JiveX (Model Number / Release: 5.3), Visus Health IT GmbH (2021) Summary page 4.

## Indications for use
JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes.

Source page: https://510kreport.com/device/K231041
Methodology: https://510kreport.com/methodology