POY · Post Breast Biopsy Hemostatic Breast Compression Device
Radiology · 21 CFR 892.1710 · Class 2
Overview
| Product Code | POY |
|---|---|
| Device Name | Post Breast Biopsy Hemostatic Breast Compression Device |
| Regulation | 21 CFR 892.1710 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163388 | XPress BCD Breast Compression Device | Xpress Bcd, LLC | Jul 19, 2017 | SESE |
Top Applicants
- Xpress Bcd, LLC — 1 clearance
