Swoop Transmit and Receive Radio Frequency Head Coil 900-11015-01

GUDID 00850043319184

The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array.

Hyperfine Operations, Inc.

MRI system coil, radio-frequency

• Primary Device ID: 00850043319184
• NIH Device Record Key: 199face3-1445-460e-a89f-635e1666a603
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swoop Transmit and Receive Radio Frequency Head Coil
• Version Model Number: v2.2
• Catalog Number: 900-11015-01
• Company DUNS: 051795046
• Company Name: Hyperfine Operations, 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: false
• 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	00850043319184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250236

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: 2025-12-12
• Device Publish Date: 2025-12-04

Devices Manufactured by Hyperfine Operations, Inc.

• 00850043319160 - Swoop Portable MR Imaging Scanner: 2025-12-12 Portable MR Scanner (v2.2)
• 00850043319184 - Swoop Transmit and Receive Radio Frequency Head Coil: 2025-12-12The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array.
• 00850043319184 - Swoop Transmit and Receive Radio Frequency Head Coil: 2025-12-12 The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is us
• 00850043319047 - Hyperfine Foam Head Pad: 2025-03-13 Memory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure.