DeviceClearance

neuro42 MRI System— 510(k) K232644

Substantially Equivalent

Neuro42, Inc.

FDA 510(k) clearance K232644 for neuro42 MRI System, Substantially Equivalent on 2024-02-08. Applicant: Neuro42, Inc.. Device class: 2.

Clearance details

Applicant
Neuro42, Inc.
Product code
Code LNH
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LNH

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Adverse events under product code LNH

product code LNH
Death
11
Injury
670
Malfunction
1,460
Other
2
Total
2,143

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.