MeVis AVM Contour— 510(k) K260576
Substantially EquivalentMeVis Medical Solutions AG
FDA 510(k) clearance K260576 for MeVis AVM Contour, Substantially Equivalent on 2026-06-30. Applicant: MeVis Medical Solutions AG. Device class: 2.
Summary
MeVis AVM Contour comes from MeVis Medical Solutions and is filed under LLZ, radiological image processing systems. The record doesn't say what "AVM" refers to or describe the product beyond the code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
MeVis filed from Bremen, Germany. The decision came 130 calendar days after receipt (February 20 to June 30, 2026).
Clearance details
- Applicant
- MeVis Medical Solutions AG
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bremen, DE
Recent devices under product code LLZ
view allMore clearances from MeVis Medical Solutions AG
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.