Image-Arena Applications Model Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, 4D LV-Analysis MR 1.0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K082510 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
- Models / Variants
- Image-Arena Va Platform 1.0 FDA 510(k)4d Lv-Analysis 2.5 FDA 510(k)4d Lv-Analysis Mr 1.0 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 Image-Arena Applications are software tools designed for medical imaging analysis. These applications include the Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, and 4D LV-Analysis MR 1.0, which are used to process and evaluate diagnostic imaging data.
This software is supplied by Tomtec Imaging Systems GmbH and has received FDA 510(k) clearance. It is intended for use in a clinical setting as part of radiological imaging workflows.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082510 | Class II | Active |
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Manufacturer
- Manufacturer
- Tomtec Imaging Systems GmbH
Sources (1)
- FDA 510(k) K082510 24 fields · synced Sep 23, 2026