Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

What Is It?

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.

How Is OUO Classified?

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance is FDA product code OUO, Class 2, 21 CFR 892.1200.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 4 clearances under this code; the FDA took a median of 101 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 9 recalls under this product code since 2012. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Software design (4), Device Design (1) and Process change control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.