Densitometer, Bone

How Is KGI Classified?

Densitometer, Bone is FDA product code KGI, Class 2, 21 CFR 892.1170.

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. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 26 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Software design (10), Radiation Control for Health and Safety Act (9) and Component design/selection (4).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.