FDA product code MWW: Accessory - Film Dosimetry System

MWW is the FDA product code for accessory - film dosimetry system. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. Devices under MWW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameAccessory - Film Dosimetry System
Device classClass II
Regulation21 CFR 892.5050
Review panelRA — Radiology
Medical specialtyRadiology
Premarket route510(k) exempt

Recalls for MWW devices

openFDA lists no recalls for product code MWW.

Frequently asked questions

What is FDA product code MWW?

MWW is the FDA product code for accessory - film dosimetry system. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.

What device class is MWW?

Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k) exempt.

Next steps

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.

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