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510(k) Data Aggregation
K Number
K232644Device Name
neuro42 MRI System
Manufacturer
Date Cleared
2024-02-08
(162 days)
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Neuro42, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The neuro42 Magnetic Resonance Imaging System 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, the images can provide diagnostically useful information.
Device Description
neuro42 MRI System is a low-field MR system intended to be used for neuroimaging. The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device intended to be used for producing images that display the internal structure of the head. The device is a low-field magnetic resonance system and includes a movable magnet cart on wheels connected to a separate electronic cabinet on wheels. The system utilizes a permanent Halbach magnet array and does not require any external shielding.
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