QVW — Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led Class N
FDA product code QVW covers "Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QVW
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Unknown
- Implant
- No
Definition
Generator, measurement, and/or delivery system for hyperpolarized MR imaging agents, and accessories, are devices that generate a hyperpolarized MR imaging agent, monitor the dose equivalent volume of the dispensed dose, and/or store, transport or administer the imaging agent to the patient