Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner

GUDID 00860000606172

Swoop POC MRI Scanner (Mk1.8 version)

HYPERFINE RESEARCH, INC.

Extremity MRI system, permanent magnet Extremity MRI system, permanent magnet Extremity MRI system, permanent magnet Extremity MRI system, permanent magnet Extremity MRI system, permanent magnet Extremity MRI system, permanent magnet Extremity MRI system, permanent magnet

• Primary Device ID: 00860000606172
• NIH Device Record Key: 768d698d-a98a-4bc1-b122-7152ec3d95d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner
• Version Model Number: 850-11001-05
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000606172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201722

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: 2021-08-03
• Device Publish Date: 2021-07-26

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: 2023-02-23 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: 2021-08-03Swoop 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