Swoop Portable MRI Scanner

GUDID 00850043319009

Swoop Portable MRI Scanner (Mk1.9)

HYPERFINE RESEARCH, INC.

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• Primary Device ID: 00850043319009
• NIH Device Record Key: 23e46fa6-5521-4192-8c87-a75060f88a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swoop Portable MRI Scanner
• Version Model Number: 850-11001-06
• 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	00850043319009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221923

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2023-02-23
• Device Publish Date: 2023-02-15

Devices Manufactured by HYPERFINE RESEARCH, INC.

• 00850043319023 - Swoop Transmit and Receive Radio Frequency Head Coil: 2023-02-24 Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.9)
• 00850043319009 - Swoop Portable MRI Scanner: 2023-02-23Swoop Portable MRI Scanner (Mk1.9)
• 00850043319009 - Swoop Portable MRI Scanner: 2023-02-23 Swoop Portable MRI Scanner (Mk1.9)
• 00860000606165 - Swoop Transmit and Receive Radio Frequency Head Coil: 2021-08-03 Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.8 version)
• 00860000606172 - Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner: 2021-08-03 Swoop POC MRI Scanner (Mk1.8 version)
• 00860000606189 - BrainInsight: 2021-03-15
• 00860000606134 - Swoop Site Quality Assurance Phantom: 2020-09-24 The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly qual
• 00860000606141 - Swoop Point-of-Care Magnetic Resonance Imaging Scanner: 2020-09-24 The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging
• 00860000606158 - Swoop Transmit and Receive Radio Frequency Head Coil: 2020-09-24 The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is us