FDA product code QVW: Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led
QVW is the FDA product code for generator, measurement, and/or delivery system for hyperpolarized mr imaging agents and accessories, cder or cber-led. It is a Not classified device, reviewed by the Radiology panel. Devices under QVW reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
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
Classification
| Field | Value |
|---|---|
| Device name | Generator, Measurement, And/Or Delivery System For Hyperpolarized Mr Imaging Agents And Accessories, Cder Or Cber-Led |
| Device class | Not classified |
| Review panel | RA — Radiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QVW devices
openFDA lists no recalls for product code QVW.
Frequently asked questions
What is FDA product code QVW?
QVW is the FDA product code for generator, measurement, and/or delivery system for hyperpolarized mr imaging agents and accessories, cder or cber-led. It is a Not classified device, reviewed by the Radiology panel.
What device class is QVW?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QVW
- Run a recall and safety report across every QVW manufacturer
- Watch product code QVW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.