Device, Digital Image Storage, Radiological

What Is It?

Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.

What Is FDA Product Code LMB?

Device, Digital Image Storage, Radiological is FDA product code LMB, Class 1, 21 CFR 892.2010.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 19 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Software design (10) and Device Design (1).

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