FDA 510(k) K232644, neuro42 MRI System, by Neuro42, Inc.
FDA 510(k) K232644, neuro42 MRI System, by Neuro42, Inc.
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
510(k) Number: K232644
Device Name: neuro42 MRI System
Applicant: Neuro42, Inc.
Regulation Number: 892.1
Classification Product Code: LNH
Date Received: 2023-08-30
Decision Date: 2024-02-08
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology
Total number of pages: 2,400
Fully redacted pages: 2,042
Content pages: 358
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