RFT 5869241-2

GUDID 06938146600102

The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.

Shenzhen RF Tech Co., Ltd.

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• Primary Device ID: 06938146600102
• NIH Device Record Key: 4b0b198a-54a3-4b32-9f3e-0cdedadad4d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RFT
• Version Model Number: 10-F31896
• Catalog Number: 5869241-2
• Company DUNS: 530798780
• Company Name: Shenzhen RF Tech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 Dimensions

• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter
• Width: 403 Millimeter
• Height: 325 Millimeter
• Depth: 358 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938146600102 [Primary]
GS1	16938146600123 [Package]; Package: Carton Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223225

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-17
• Device Publish Date: 2023-04-08

On-Brand Devices [RFT]

• 16938146600055: 1.5T 8ch Flex 40 Array (A-port)
• 16938146600048: 1.5T 8ch Flex 50 Array (A-port)
• 16938146600031: 1.5T 8ch Flex 70 Array (A-port)
• 16938146600024: 1.5T 8ch Foot Ankle Coil
• 06938146600010: 3.0T 8ch Foot Ankle Coil
• 16938146600086: 8ch Flex 40 Array
• 16938146600079: 8ch Flex 50 Array
• 06938146600065: 8ch Flex 70 Array
• 06938146600119: The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to b
• 06938146600102: The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is d
• 16938146600130: The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed