Identity
- Device Name
- AMRA Profiler 4 EUDAMED
- Model / Reference
- 041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350140460411 EUDAMED
- Basic UDI-DI
- 7350140460417Q EUDAMED
- EMDN Code
- Z11059082 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
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
Amra Profiler 4 is an AI-powered medical device that analyzes MRI images to quantify and classify fat and muscle composition. It provides individualized insights into body composition by utilizing an automated method to process MRI data.
This device is intended for use in clinical and research settings. It is supplied as a non-sterile, single-use software tool that holds FDA 510(k) clearance and MDR certification.
Frequently asked questions
What is the primary function of the AMRA Profiler 4?
The AMRA Profiler 4 is an AI-powered medical device designed to analyze MRI images. It utilizes an automated method to quantify and classify body composition, specifically focusing on fat and muscle tissue to provide individualized clinical and research insights.
Is the AMRA Profiler 4 a reusable medical device?
No, the AMRA Profiler 4 is a single-use software tool. It is provided as a non-sterile digital solution intended for processing MRI data within clinical and research environments.
What regulatory certifications does this device hold?
The AMRA Profiler 4 holds FDA 510(k) clearance and is MDR certified. These authorizations confirm that the software meets the necessary regulatory requirements for its intended use in analyzing body composition via MRI 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. Sources consulted: AMRA Medical | Advanced Medical Imaging, AMRA Medical Launches AMRA® Profiler 4 in Sweden and Germany ..., AMRA Profiler Review: Pricing, FDA Status & Alternatives | Physician AI ..., AMRA ® Profiler 4 Pilot Study Demonstrates Feasible Assessment of ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211983 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K173749 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 7350140460417Q | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMRA Medical AB
- EUDAMED SRN
- SE-MF-000008820
Sources (2)
- EUDAMED 45b68141-a640-4e52-b5b5-381e97af5b6c 61 fields · synced Sep 22, 2026
- FDA 510(k) K211983 1 fields · synced May 18, 2026