Automated Breast Ultrasound
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
- GE Medical Systems (China) Co., Ltd. Jiangsu, contract manufacturer
What Is It?
Adjunct to mammography for breast cancer screening and diagnosis.
What Is FDA Product Code PAA?
Automated Breast Ultrasound is FDA product code PAA, Class 3.
How Does It Reach the US Market?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Software design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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