Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
The Generator, Measurement, and/or Delivery System for Hyperpolarized MR Imaging Agents and Accessories is a device system used to generate hyperpolarized MR imaging agents at the point of care, monitor the volume of dispensed doses, and/or store, transport, or administer the imaging agent to patients undergoing hyperpolarized MRI examinations. This device carries a status of "not classified," as it is regulated primarily in conjunction with CDER- or CBER-led drug or biologic products and falls outside standard device classification pathways. It is reviewed under the Radiology panel and is not an implant or life-sustaining.
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Basic Information
- Product Code
- QVW
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- RA
- Submission Type
- 3
Device Characteristics
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
Unclassified Reason
4
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.