1.5T 16Ch Breast Coil

GUDID 00856181003893

The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.

NEOCOIL, LLC

MRI system coil, radio-frequency

• Primary Device ID: 00856181003893
• NIH Device Record Key: f3423694-c27e-4c10-9d1d-3a2d65a1001b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5T 16Ch Breast Coil
• Version Model Number: 89
• Company DUNS: 781155176
• Company Name: NEOCOIL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856181003893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182958

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-06-10

On-Brand Devices [1.5T 16Ch Breast Coil]

• 00856181003893: The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, a
• 00850028932469: 46