32Ch Head Coil

GUDID 00857371006007

The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 1H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.

M R Instruments, Inc.

MRI system coil, radio-frequency

• Primary Device ID: 00857371006007
• NIH Device Record Key: 4287da1d-1dc4-462c-9839-bd869ddd88f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 32Ch Head Coil
• Version Model Number: MC 3003G-32R
• Company DUNS: 112719096
• Company Name: M R Instruments, Inc.
• 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	00857371006007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072931

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: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-06-21

Devices Manufactured by M R Instruments, Inc.

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• 00857371006144 - DuoFLEX® Coil Suite: 2022-03-18 The 10cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000G-8R DuoFLEX® Coil Suite includes
• 00857371006151 - DuoFLEX® Coil Suite: 2022-03-18 The 10cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000G-8R DuoFLEX® Coil Suite include
• 00857371006168 - DuoFLEX® Coil Suite: 2022-03-18 The 24cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000G-8R DuoFLEX® Coil Suite includes
• 00857371006175 - DuoFLEX® Coil Suite: 2022-03-18 The 24cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000G-8R DuoFLEX® Coil Suite include
• 00857371006205 - DuoFLEX® Coil Suite: 2022-03-18 The Preamplifier Box is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1500S-8R DuoFLEX® Coil Suite includes two di
• 00857371006212 - DuoFLEX® Coil Suite: 2022-03-18 The 10cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1500S-8R DuoFLEX® Coil Suite includes
• 00857371006229 - DuoFLEX® Coil Suite: 2022-03-18 The 10cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1500S-8R DuoFLEX® Coil Suite include