CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES > SUBPART C—Obstetrical and Gynecological Monitoring Devices (§884.2050 to §884.2990) > 884.2990—Breast lesion documentation system.

884.2990—Breast lesion documentation system.

(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.

Code of Federal Regulations

[68 FR 44415, Aug. 27, 2003]