Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
Medical specialty
Unknown
Device class
N
Review panel
RA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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