21 C.F.R. § 884.2990 Breast lesion documentation system.
Title 21 - Food and Drugs
(a) Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination. (b) Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See §884.1(e) for the availability of this guidance document. [68 FR 44415, Aug. 27, 2003]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart C—Obstetrical and Gynecological Monitoring Devices
§ 884.2990 Breast lesion documentation system.
