1.5T 8ch Shoulder Coil

GUDID 00856181003046

The NeoCoil 1 ST 8-Channel Shoulder Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the shoulder in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its unique eight channel layout and a larger field-of-view due to the antenna layout.

NEOCOIL, LLC

MRI system coil, radio-frequency

• Primary Device ID: 00856181003046
• NIH Device Record Key: 8bb733ca-8440-4ad2-84dc-02262603ff2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5T 8ch Shoulder Coil
• Version Model Number: 04
• 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: true
• 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	00856181003046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071311

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: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-03-07

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• 00856181003916 - 1.5T 16ch Shoulder Coil (Device): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover
• 00856181003947 - 3.0T 16ch Shoulder Coil (FRU): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover
• 00856181003954 - 1.5T 16ch Shoulder Coil (FRU): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover
• 00856181003961 - 16ch Shoulder Coil, Replacement Pad Kit (FRU): 2021-01-12 The 16ch Shoulder Coil is a receive-only phased array RF coil designed for optimum signal-to-noise ratio (SNR) and uniform cover