NKA · System, Documentation, Breast Lesion
Obstetrics/Gynecology · 21 CFR 884.2990 · Class 2
Overview
| Product Code | NKA |
|---|---|
| Device Name | System, Documentation, Breast Lesion |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190575 | iBreastExam | Ue Lifesciences, Inc. | Jul 16, 2019 | SESE |
| K181672 | SureTouch Mobile Pressure Mapping System | Sure, Inc. | Jun 28, 2019 | SESE |
| K142926 | iBreastExam | Ue Lifesciences, Inc. | Apr 23, 2015 | SESE |
| DEN020001 | BREASTVIEW VISUAL MAPPING SYSTEM | Assurance Medical | Jan 31, 2003 | DENG |
Top Applicants
- Ue Lifesciences, Inc. — 2 clearances
- Assurance Medical — 1 clearance
- Sure, Inc. — 1 clearance
