HYPERFINE RESEARCH, INC.

Address:351 New Whitfield Street,Guilford,CT,06437,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Nuclear Magnetic Resonance Imaging (LNH) (3) Coil, Magnetic Resonance, Specialty (MOS) (2) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

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Swoop Site Quality Assurance Phantom - 00860000606134 Catalog Number :

Device Description : The Site Quality Assurance Phantom is specifically designed as a medical device The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment.

Device Class : 2

Duns Number: 051795046

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Swoop Point-of-Care Magnetic Resonance Imaging Scanner - 00860000606141 Catalog Number :

Device Description : The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device t The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts.The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.

Device Class : 2

Duns Number: 051795046

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

Swoop Transmit and Receive Radio Frequency Head Coil - 00860000606158 Catalog Number :

Device Description : The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conven 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.

Device Class : 2

Duns Number: 051795046

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Swoop Transmit and Receive Radio Frequency Head Coil - 00860000606165 Catalog Number :

Device Description : Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC M Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.8 version)

Device Class : 2

Duns Number: 051795046

Premarket Exempt : No

Product Code : MOS

Prescription Use : Yes

Device Count : 1

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner - 00860000606172 Catalog Number :

Device Description : Swoop POC MRI Scanner (Mk1.8 version)

Device Class : 2

Duns Number: 051795046

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

BrainInsight - 00860000606189 Catalog Number :

Device Class : 2

Duns Number: 051795046

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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