Swoop Transmit and Receive Radio Frequency Head Coil

GUDID 00850043319023

Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.9)

HYPERFINE RESEARCH, INC.

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• Primary Device ID: 00850043319023
• NIH Device Record Key: 76daee76-ae1b-472b-94e3-24dace67b41c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swoop Transmit and Receive Radio Frequency Head Coil
• Version Model Number: 900-11011-06
• Company DUNS: 051795046
• Company Name: HYPERFINE RESEARCH, 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	00850043319023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221923

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: 2023-02-24
• Device Publish Date: 2023-02-16

On-Brand Devices [Swoop Transmit and Receive Radio Frequency Head Coil]

• 00860000606158: The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-fiel
• 00860000606165: Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.
• 00850043319023: Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.