applicable medical imaging device
Defined in 2 places of the United States Code.
the term “applicable medical imaging device” means 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); and
Source
- 2017–present21 U.S.C. § 360JFood and Drugs · General provisions respecting control of devices intended for human use · under this chapter
the terms “applicable medical imaging device” and “contrast agent” have the meanings given such terms in section 360j(p) of this title.
Source
- 2017–present21 U.S.C. § 355Food and Drugs · New drugs · under this section