3T 16ch Flex SPEEDER Medium

GUDID 00856181003251

The NeoCoil 3T l6ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis. head, neck, and spine. The system is compatible with 20, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction.

NEOCOIL, LLC

MRI system coil, radio-frequency

• Primary Device ID: 00856181003251
• NIH Device Record Key: ca686b68-7329-42c6-8957-46831640e13e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3T 16ch Flex SPEEDER Medium
• Version Model Number: 25
• 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	00856181003251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141832

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: 2017-03-16

Devices Manufactured by NEOCOIL, LLC

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• 00850028932469 - 1.5T 16ch Breast Coil: 2023-03-31
• 00850028932513 - Biopsy Grid Assembly, Pack, Breast Coil: 2023-03-31
• 00850028932520 - Drape Pack, Biopsy, Breast Coil: 2023-03-31
• 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