BREASTVIEW VISUAL MAPPING SYSTEM
Device Facts
| Record ID | DEN020001 |
|---|---|
| Device Name | BREASTVIEW VISUAL MAPPING SYSTEM |
| Applicant | Assurance Medical |
| Product Code | NKA · Obstetrics/Gynecology |
| Decision Date | Jan 31, 2003 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 884.2990 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 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.
