1.5T DuoFLEX Standard Suite

GUDID 00857371006014

The MR Instruments FC 1500G-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging.

M R Instruments, Inc.

MRI system coil, radio-frequency

• Primary Device ID: 00857371006014
• NIH Device Record Key: 98046d6c-3250-4a73-86b8-84b6a8db6e1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5T DuoFLEX Standard Suite
• Version Model Number: FC 1500G-8R
• 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: true
• 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	00857371006014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130706

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: 2016-07-25

Devices Manufactured by M R Instruments, Inc.

• 00857371006137 - DuoFLEX® Coil Suite: 2022-03-18 The Preamplifier Box is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000G-8R DuoFLEX® Coil Suite includes two di
• 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