Jive X Software
by Visus Technology Transfer GmbH
510(k) K053183
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053183 | Date16 Feb 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
JiveX Software is a Picture Archiving and Communication System (PACS) designed for radiology workflows. It enables the storage, retrieval, and display of radiological image data, supporting efficient diagnostic processes and integration with medical imaging standards such as DICOM and IHE. The system consolidates diverse medical imaging formats into a unified platform for parallel viewing and secure archiving.
The software is supplied as a standalone application for use in radiology departments, hospitals, or clinical settings where digital image management is required. It operates on standard IT infrastructure and is intended for single-use in institutional environments, though its regulatory status includes FDA 510(k) clearance (K053183) under the Radiology advisory committee. No sterility or single-use packaging is applicable, as it is a software solution rather than a physical device.
Other devices from Visus Technology Transfer GmbH
Questions
AI-generated answers, 1 Oct 2026
What is JiveX Software used for in clinical settings?
JiveX Software is a Picture Archiving and Communication System (PACS) designed specifically for radiology workflows. It consolidates diverse radiological image formats into a single platform, allowing clinicians to store, retrieve, and display images efficiently. This streamlines diagnostic processes by supporting integration with medical imaging standards like DICOM and IHE, ensuring seamless workflows in hospitals or clinical environments where digital image management is required.
How is JiveX Software supplied and what infrastructure does it require?
JiveX Software is supplied as a standalone application and does not require physical packaging or sterility measures, as it is a software solution rather than a hardware device. It operates on standard IT infrastructure, meaning it can be installed on existing hospital or departmental networks to manage and archive radiological images without needing specialized hardware.
Is JiveX Software intended for single-use or reuse in institutional settings?
JiveX Software is designed for institutional use and is not packaged for single-use like a disposable device. Instead, it is deployed as a permanent software solution within radiology departments or hospitals, allowing continuous use for image management and diagnostic support. Its regulatory clearance reflects this intended use in clinical environments.
What standards does JiveX Software support for image compatibility and workflow integration?
JiveX Software supports DICOM (Digital Imaging and Communications in Medicine) and IHE (Integrating the Healthcare Enterprise) standards. These standards ensure compatibility with a wide range of medical imaging devices and enable seamless integration across different systems, improving interoperability and efficiency in radiology workflows.
What regulatory pathway does JiveX Software follow, and what does this mean for its use?
JiveX Software follows the FDA 510(k) clearance pathway, specifically under the Radiology advisory committee (K053183). This clearance indicates that the device has been deemed substantially equivalent to a predicate device already on the market, ensuring it meets regulatory standards for safety and effectiveness in radiology workflows. Clinicians and institutions can rely on this clearance as part of their evaluation when adopting the software.