Identity
- Trade Name
- Intuition EUDAMED
- Device Name
- Intuition EUDAMED
- Model / Reference
- 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B220INTUITION040 EUDAMED
- Basic UDI-DI
- ++B220INTUITIONFV EUDAMED
- Direct Marketing DI
- +B220INTUITION040 EUDAMED
- 510(k) Number
- K121916 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Intuition is a Radiology Workstation (Product Code: LLZ) designed for advanced medical imaging visualization and post-processing. It provides tools for comprehensive analysis of radiologic images, including cardiac imaging, enabling precise diagnostic assessments through automated and AI-assisted workflows.
The device is supplied as a software platform, intended for use in clinical radiology settings. It operates on a cloud-based infrastructure and is intended for single-use per session, though the software itself may be reused across multiple imaging studies. No specific sterility or MRI safety classifications are stated in the provided data, and regulatory authorizations include FDA 510(k) clearance under the Traditional pathway, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR).
Frequently asked questions
What types of medical imaging studies is the Intuition Radiology Workstation primarily designed to analyze and assist with?
The Intuition Radiology Workstation is specifically designed for advanced visualization and post-processing of radiologic images, with a focus on cardiac imaging. It includes automated and AI-assisted tools to help clinicians perform precise diagnostic assessments, making it particularly useful for detailed cardiac evaluations and other complex imaging studies.
Is the Intuition software intended for single-use or can it be reused across multiple imaging sessions?
The Intuition software itself is designed for reuse across multiple imaging studies, but it is intended for single-use per clinical session. This means the software platform can be utilized repeatedly for different patients, but each session’s data and workflow are treated as a distinct use case within that session.
How is the Intuition Radiology Workstation supplied, and does it require any special handling or storage conditions?
Intuition is supplied as a cloud-based software platform, meaning it does not require physical storage like traditional hardware. Since it is software-based, there are no sterility concerns or special handling requirements related to physical packaging. However, the facility using it must ensure proper IT infrastructure, network connectivity, and compliance with cloud-based data security protocols.
What regulatory pathways has the Intuition Radiology Workstation undergone, and which advisory committee was involved in its review?
The Intuition Radiology Workstation has undergone FDA clearance through the Traditional 510(k) pathway, with a decision classified as Substantially Equivalent under Product Code LLZ (Radiology). The review was conducted by the Radiology (RA) Advisory Committee. Additionally, it complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR).
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. Sources consulted: TeraRecon Intuition, TeraRecon Intuition - concertai.com, Intuition - concertai.com, TeraRecon's New Intuition Product Line Delivers AI Productivity and ...
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 | K121916 | Class II | Active |
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Manufacturer
- Manufacturer
- Terarecon Inc.
- FDA Applicant
- Terarecon,Inc.
Sources (2)
- FDA 510(k) K121916 24 fields · synced Sep 18, 2026
- EUDAMED 4ed5274f-f127-408a-b96f-2f0f64cea189 61 fields · synced Jul 12, 2026