MRI conditional labeling
FDA-approved device labeling that specifies exact conditions under which MRI scanning is safe for patients with cardiac devices.
Full Definition
Regulatory labeling that defines the specific technical parameters and clinical conditions under which magnetic resonance imaging can be safely performed in patients with cardiac devices. MRI conditional labeling includes detailed specifications for magnetic field strength, specific absorption rate limits, patient positioning, device programming requirements, and monitoring protocols. This labeling represents a significant advancement from earlier devices that were contraindicated for MRI, requiring extensive clinical testing to demonstrate safety under defined conditions.
Usage
Usage note: Use 'conditional' not 'compatible' or 'safe' when referring to regulatory labeling.
In Context
- "The MRI conditional labeling specifies 1.5 Tesla field strength limitations." — Product labeling document
- "Hospitals must follow MRI conditional labeling requirements precisely." — Clinical procedure manual