FDA product code QVW

Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led

Unknown·Class N·21 CFR
US regulatory classifications
US Product Code (FDA)
QVW
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US Risk Class (FDA)
Class N
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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

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About this record

Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.