2D Cardiac Performance Analysis MR 1.0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120135 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)
2D Cardiac Performance Analysis MR is a clinical application package indicated for cardiac quantification based on digital magnetic resonance images. It provides measurements of myocardial function, including displacement, velocity, and strain, used for clinical diagnosis of patients with suspected heart disease.
The device is supplied as software for use in radiology settings. It received FDA 510(k) clearance under K-number K120135 in 2012 and is classified as substantially equivalent to a predicate device. It is manufactured by Tomtec Imaging Systems GmbH and is intended for use with digital MR image data.
Frequently asked questions
What is the 2D Cardiac Performance Analysis MR 1.0 used for?
It is a clinical application package indicated for cardiac quantification based on digital magnetic resonance images, providing measurements of myocardial function including displacement, velocity, and strain to aid in the clinical diagnosis of patients with suspected heart disease.
How is the 2D Cardiac Performance Analysis MR 1.0 supplied and what type of data does it require?
The device is supplied as software for use in radiology settings and is intended for use with digital MR image data, requiring no additional hardware beyond standard imaging workstations capable of processing such data.
Is the 2D Cardiac Performance Analysis MR 1.0 a single-use or reusable software product?
As a software application, it is designed for reusable use in clinical environments, allowing multiple analyses on different patient datasets over time without consumption or degradation from use, consistent with standard medical software deployment.
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: 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 - Innolitics, Tomtec 2D Cardiac Performance Analysis MR 1.0 | allmed.wiki, Image-arena 4.0 and Ia Applications 2d Cardiac Performance Analysis 1.0 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120135 | Class II | Active |
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Manufacturer
- Manufacturer
- Tomtec Imaging Systems GmbH
Sources (1)
- FDA 510(k) K120135 24 fields · synced Sep 28, 2026