Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1710](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1710) → POY — Post Breast Biopsy Hemostatic Breast Compression Device

# POY · Post Breast Biopsy Hemostatic Breast Compression Device

_Radiology · 21 CFR 892.1710 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/POY

## Overview

- **Product Code:** POY
- **Device Name:** Post Breast Biopsy Hemostatic Breast Compression Device
- **Regulation:** [21 CFR 892.1710](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1710)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/POY/K163388.md) | XPress BCD Breast Compression Device | Xpress Bcd, LLC | Jul 19, 2017 | SESE |

## Top Applicants

- Xpress Bcd, LLC — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/POY](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/POY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com