OBC-085 Breast Array Coil

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

510(k) Number

K993233 ↗

FDA Product Code

MOS

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Mri Devices Corp. →

• Is the OBC-085 Breast Array Coil designed for single-use or can it be reused in multiple MRI procedures?

  The OBC-085 Breast Array Coil is explicitly supplied as a reusable accessory for MRI scanners, requiring no sterilization between uses. Its design and regulatory classification as a reusable device (Class II) confirm this, so it is intended for repeated use in compatible MRI systems.

• What regions of the body does this coil specifically enhance imaging for during MRI procedures?

  The OBC-085 Breast Array Coil is engineered to improve MRI signal reception from breast tissue, the chest wall, and the axillary (underarm) regions. This targeted design helps clinicians achieve clearer diagnostic images in these critical areas.

• How is compatibility with MRI systems ensured for this device?

  Compatibility and safety of the OBC-085 Breast Array Coil are governed by FDA regulation number 892.1000, which outlines MRI-specific standards. The device adheres to these guidelines to ensure it functions safely and effectively within MRI-compatible clinical settings.

• What regulatory pathway was used to clear this device, and what does that mean for its use?

  The OBC-085 Breast Array Coil received FDA clearance through a Special 510(k) pathway (K993233), with a decision dated 1999-10-15. This means the manufacturer demonstrated its substantial equivalence to a legally marketed predicate device, confirming it meets FDA safety and performance requirements for use as a reusable MRI accessory.

• Are there multiple models or sizes available for this coil, or is it a single standardized unit?

  While the provided data does not specify exact variations in size or model numbers beyond the OBC-085 designation, the OpenFDA registration numbers (e.g., 3009529630, 1000114185) suggest multiple variants may exist for different MRI systems or clinical applications. For precise sizing or model availability, consulting the manufacturer’s technical documentation or support team is recommended.