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510(k) Data Aggregation
K Number
K201722Device Name
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Manufacturer
Hyperfine Research, Inc.
Date Cleared
2020-08-11
(49 days)
Product Code
LNH, MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Hyperfine Research, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Point-of-Care Magnetic Resonance Imaging Device is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Description
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.
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K Number
K192002Device Name
Lucy Point-of-Care Magnetic Resonance Imaging Device
Manufacturer
Hyperfine Research, Inc.
Date Cleared
2020-02-06
(195 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Hyperfine Research, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lucy Point-of-Care Magnetic Resonance Imaging Device is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Description
Lucy is a magnetic resonance imaging (MRI) device. Its portability allows 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. Lucy 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.
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