# K162008: JiveX

- Pathway: 510(k) (Traditional)
- Applicant: Visus Technology Transfer GmbH
- Decided: Sep 16, 2016 after 58 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: 10 generations back to K971684 (1997). 28 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142750: JiveX, Visus Technology Transfer GmbH (2015) Summary page 5.

## Most influential descendants
- K181964: JiveX (2018), 3 descendants of its own
- K200703: JiveX (2020), 2 descendants of its own
- K212321: JiveX (Model Number / Release: 5.3) (2021), 1 descendant of its own
- K231041: JiveX (Model Number / Release: 5.4) (2023), 0 descendants of its own

## 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. Also monitors (displays) and printers which received FDA clearance for Mammography 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 are not intended for diagnostic purposes.

Source page: https://510kreport.com/device/K162008
Methodology: https://510kreport.com/methodology