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Open Breast Coil (OBC) With Biopsy Plates

by USA Instruments, Inc. United States(FDA 510(k) applicant) 510(k)

510(k) K050728 Product code MOS

Overview

The Open Breast Coil (OBC) With Biopsy Plates is a phased array, receive-only MRI coil used for obtaining MR images of the breast and auxiliary tissue. It is a specialty coil, classified as a Magnetic Resonance Coil. The device is designed to work with MRI systems to provide high-quality images for diagnostic purposes.

The Open Breast Coil (OBC) With Biopsy Plates is supplied with biopsy plates and is intended for use in radiology applications. It has been cleared by the FDA under the 510(k) premarket notification, with the clearance number K050728. The device is manufactured by Usa Instruments, Inc. and is registered with the FDA under the product code MOS and regulation number 892.1000.

Summary written by AI from registry data, 21 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK050728 Date28 Jun 2005ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from USA Instruments, Inc.

See all devices from USA Instruments, Inc. →

Questions

  • What is the Open Breast Coil used for?

    The Open Breast Coil is used for obtaining MR images of the breast and auxiliary tissue for diagnostic purposes.

  • Is the Open Breast Coil supplied with any additional components?

    Yes, the Open Breast Coil is supplied with biopsy plates.

  • What type of MRI systems is the Open Breast Coil compatible with?

    The Open Breast Coil is designed to work with MRI systems to provide high-quality images for diagnostic purposes, but specific compatibility details are not provided.

  • What is the regulatory status of the Open Breast Coil?

    The Open Breast Coil has been cleared by the FDA under the 510(k) premarket notification, with the clearance number K050728.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K050728 24 fields · synced 22 Oct 2026