Intuition - TDA, TVA, Parametric Mapping
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131447 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)
The Intuition - TDA, TVA, Parametric Mapping is a medical imaging software system designed for advanced radiology workflows. It integrates time-domain analysis (TDA), time-volume analysis (TVA), and parametric mapping to enhance diagnostic imaging, particularly in cardiac and tissue characterization studies.
This software is supplied as a standalone application for use in radiology departments and imaging centers, requiring integration with existing imaging modalities. It is intended for single-use sessions per patient study, with no explicit sterility requirements as it is non-invasive and non-contact. The system operates under FDA 510(k) clearance (K131447) and complies with EU Medical Device Directives (MDD) and the Medical Device Regulation (MDR).
Frequently asked questions
What types of imaging studies is this software designed to enhance, and how does it improve diagnostic accuracy?
The Intuition software is specifically designed to enhance cardiac and tissue characterization studies by integrating time-domain analysis (TDA), time-volume analysis (TVA), and parametric mapping. These advanced techniques provide deeper insights into tissue properties and blood flow dynamics, helping radiologists make more precise diagnostic assessments during imaging sessions.
Is this software intended for repeated use with the same patient, or is it meant for single-use per study?
The Intuition software is intended for single-use per patient study, meaning it is configured and utilized for one diagnostic session before being reset or reconfigured for the next patient. Since it is a non-invasive, non-contact system, there are no sterility requirements, but it is not designed for reuse with the same patient across multiple sessions.
How does a radiology department integrate this software with their existing imaging equipment?
The Intuition software is supplied as a standalone application that requires integration with existing imaging modalities (such as MRI or CT scanners) within radiology departments or imaging centers. While the software itself does not replace hardware, it enhances workflows by processing and analyzing imaging data from these systems to provide advanced diagnostic insights.
What regulatory pathways does this software follow, and which governing bodies have approved its use?
The Intuition software has undergone FDA 510(k) clearance (K131447) under the Traditional Review pathway, with a Substantially Equivalent determination by the Radiology (RA) Advisory Committee. It also complies with EU Medical Device Directives (MDD) and the Medical Device Regulation (MDR), ensuring its use aligns with both U.S. and European regulatory standards.
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 | K131447 | Class II | Active |
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Manufacturer
- Manufacturer
- Terarecon Inc.
- FDA Applicant
- Terarecon,Inc.
Sources (2)
- FDA 510(k) K131447 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026