RFT 5932028-2

GUDID 16938146600130

The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed for use as general purpose coil. The Knee Coil is designed to be use with GEHC 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.

MRI system coil, radio-frequency

• Primary Device ID: 16938146600130
• NIH Device Record Key: 3088ee6b-64e4-4c9d-9f71-5b3d7d2ee1cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RFT
• Version Model Number: 10-F34127
• Catalog Number: 5932028-2
• 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
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938146600140 [Primary]
GS1	16938146600130 [Package]; Contains: 06938146600140; Package: Carton Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231085

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: 2023-10-17
• Device Publish Date: 2023-10-09

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