BrainInsight

GUDID 00860000606189

HYPERFINE RESEARCH, INC.

Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software Image segmentation application software

• Primary Device ID: 00860000606189
• NIH Device Record Key: b7adbf59-227a-4bb4-a1a5-e1e170d9dbde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BrainInsight
• Version Model Number: Version 1.0
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000606189 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-03-15
• Device Publish Date: 2021-03-05

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: 2021-08-03 Swoop POC MRI Scanner (Mk1.8 version)
• 00860000606189 - BrainInsight: 2021-03-15
• 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