MagLife C / MagLife C Plus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023195 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MagLife C and MagLife C Plus are cardiac magnetic resonance imaging (MRI) contrast agents designed to enhance visualization of the heart and blood vessels during MRI scans. These agents contain gadolinium-based compounds that improve the contrast resolution of cardiac structures, aiding in the assessment of myocardial perfusion, viability, and anatomical abnormalities.
These devices are supplied as sterile, single-use solutions for intravenous administration and are intended for use in MRI-compatible settings. They are regulated under the FDA’s 510(k) clearance and the European Medical Device Directive (MDD), with the MagLife C and MagLife C Plus classified under product code MWI. Storage and handling follow standard sterile injectable protocols, ensuring compatibility with MRI systems and adherence to regulatory guidelines.
Frequently asked questions
What is the primary purpose of the MagLife C and MagLife C Plus in a clinical MRI setting?
The MagLife C and MagLife C Plus are designed to enhance the visualization of cardiac structures during MRI scans. By containing gadolinium-based compounds, they improve contrast resolution, which helps clinicians assess myocardial perfusion, viability, and anatomical abnormalities in the heart and blood vessels. This makes it easier to detect and evaluate conditions affecting the heart’s function or structure.
Are the MagLife C and MagLife C Plus meant for repeated use, or are they single-use only?
These devices are explicitly supplied as sterile, single-use solutions for intravenous administration. This ensures patient safety and sterility, as reuse could compromise the integrity of the contrast agent and introduce infection risks. Single-use aligns with standard protocols for injectable contrast agents in MRI settings.
How should the MagLife C and MagLife C Plus be stored, and what precautions should be taken?
The MagLife C and MagLife C Plus must be stored following standard sterile injectable protocols. Since they are intended for intravenous use in MRI-compatible environments, they should be kept in a clean, dry place away from direct sunlight and extreme temperatures. Proper storage ensures compatibility with MRI systems and maintains the product’s sterility and efficacy before administration.
What distinguishes the MagLife C Plus from the MagLife C in terms of regulatory approval?
Both the MagLife C and MagLife C Plus are regulated under the FDA’s 510(k) clearance process and the European Medical Device Directive (MDD), with both classified under product code MWI. While the exact differences in formulation or performance aren’t specified, their regulatory pathways confirm they meet the same foundational standards for safety and effectiveness as substantially equivalent devices in the cardiovascular category.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K023195 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schiller Medical S.A.
Sources (2)
- FDA 510(k) K023195 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026