### Question
How is the term applicable medical imaging device defined?


### Answer
The term **applicable medical imaging device** is defined in *21 U.S.C. § 360j* as the following:

> a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent)

#### Citation:
  - *21 U.S.C. § 360j*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

