Identifiers
- 510(k) Number
- K103782 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
4D MV-Assessment 2.0 is a software device designed for automated quantification of valvular function and morphology. It enables dynamic 3D analysis of the mitral valve for pre- and post-operative assessment.
The device is used by cardiologists and surgeons in clinical settings and integrates with TomTec Image-Arena platforms via a Generic CAP Interface for database management, reporting, and statistical quantification. It received FDA 510(k) clearance under K103782 and is classified under product code DQK with cardiovascular advisory committee review.
Frequently asked questions
What is the primary function of the 4D MV-ASSESSMENT 2.0 software?
The 4D MV-ASSESSMENT 2.0 software is designed for automated quantification of valvular function and morphology, enabling dynamic 3D analysis of the mitral valve for pre- and post-operative assessment.
How does the 4D MV-ASSESSMENT 2.0 integrate with clinical systems?
The device integrates with TomTec Image-Arena platforms via a Generic CAP Interface for database management, reporting, and statistical quantification purposes.
What is the regulatory status of the 4D MV-ASSESSMENT 2.0?
The device received FDA 510(k) clearance under K103782 and is classified under product code DQK with cardiovascular advisory committee review.
Who is the intended user of the 4D MV-ASSESSMENT 2.0?
The device is used by cardiologists and surgeons in clinical settings for analyzing mitral valve function and morphology.
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: PDF 4D MV-Assessment 2 - accessdata.fda.gov, Tomtec 4D MV-Assessment 2.0 - allmed.wiki, 4D MV-ASSESSMENT 2.0 (K103782) — FDA 510 (k) | Innolitics, Bench to Bedside: Dynamic Mitral Valve Assessment
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103782 | Class II | Active |
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Manufacturer
- Manufacturer
- Tomtec Imaging Systems GmbH
Sources (1)
- FDA 510(k) K103782 24 fields · synced Sep 19, 2026