FDA product code OUO

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Radiology·Class 2·21 CFR 892.1200
US regulatory classifications
US Product Code (FDA)
OUO
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 892.1200
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Medical specialty
Radiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Imager that generates both both magnetic resonance (mr) and positron emission tomography (pet) images and provides registration and fusion of these images. Pet and mr images can be acquired either simultaneously or sequentially. Anatomical mr images are used for pet attenuation correction.

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About this record

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance is a medical device type in the Radiology 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.