NHM · Sheet, Recording, Breast Examination
Obstetrics/Gynecology · 21 CFR 884.2990 · Class 2
Overview
| Product Code | NHM |
|---|---|
| Device Name | Sheet, Recording, Breast Examination |
| Regulation | 21 CFR 884.2990 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022861 | SAFETOUCH | Rusin Medical Devices | Nov 26, 2002 | SESE |
| K014300 | SAFETOUCH | James D Rusin MD, MBA | Mar 1, 2002 | SESE |
Top Applicants
- James D Rusin MD, MBA — 1 clearance
- Rusin Medical Devices — 1 clearance
