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OBC-127 Breast Array Coil

by Mri Devices Corp.

510(k) K021575

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK021575 Date12 Jun 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OBC-127 Breast Array Coil is a radiofrequency (RF) receive-only coil designed for use with Magnetic Resonance (MR) scanners. It functions as an accessory to capture MR signals from the female breast, chest wall, and axillary tissues.

The device is supplied as a Class 2 medical device with product code MOS, cleared through the Special 510(k) pathway. It is manufactured by Mri Devices Corp. and received FDA clearance on June 12, 2002, with K number K021575. The device is intended for use in radiology settings.

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