Identifiers
- 510(k) Number
- K212321 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
JiveX (Model 5.3) is a radiology information system designed to facilitate the management, viewing, and analysis of medical imaging data. It integrates diagnostic imaging workflows, enabling radiologists and clinicians to access, interpret, and share digital images and reports efficiently within healthcare settings.
This software solution is supplied as a standalone system for use in radiology departments, hospitals, or imaging centers. It operates on standard IT infrastructure and requires no physical sterility or single-use considerations, though its regulatory compliance includes FDA 510(k) clearance, MDD, and MDR authorisations. The system is intended for traditional IT deployment and does not involve MRI safety classifications or physical device sterility.
Frequently asked questions
What types of healthcare settings is the JiveX radiology information system designed for, and how is it deployed?
The JiveX (Model 5.3) is designed for radiology departments, hospitals, and imaging centers. It is supplied as a standalone software solution that integrates with standard IT infrastructure, meaning it requires no specialized hardware deployment or physical installation beyond typical IT systems. Since it is a software-based system, it does not involve physical sterility or single-use considerations.
Is the JiveX system intended for use in MRI environments, and does it require any special safety classifications?
No, the JiveX system is not intended for use in MRI environments or classified under MRI safety standards. It is a radiology information system focused on managing, viewing, and analyzing digital imaging data, and its regulatory compliance does not include MRI-specific safety classifications.
How does the JiveX system ensure compliance with regulatory standards, and what types of authorizations does it hold?
The JiveX (Model 5.3) holds FDA 510(k) clearance, along with compliance under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). These authorizations confirm its regulatory standing for use in managing radiology workflows, ensuring it meets established safety and performance standards for radiology information systems.
What is the advisory committee and product code category associated with the JiveX system’s regulatory submission?
The JiveX system’s regulatory submission was reviewed by the Radiology (RA) advisory committee under product code category LLZ, which pertains to radiology information systems. This categorization reflects its intended use in managing diagnostic imaging workflows and data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212321 | Class II | Active |
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Manufacturer
- Manufacturer
- VISUS Health IT GmbH
Sources (2)
- FDA 510(k) K212321 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026