Promaxo MRI System II— 510(k) K232361

Name: FDA 510(k) clearance K232361
Creator: U.S. Food and Drug Administration
Published: 2023-09-05

Substantially Equivalent

Promaxo, Inc.

FDA 510(k) clearance K232361 for Promaxo MRI System II, Substantially Equivalent on 2023-09-05. Applicant: Promaxo, Inc.. Device class: 2.

Clearance details

Applicant: Promaxo, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2023-08-07
Decision date: 2023-09-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Oakland, CA, US

Download summary PDF View on FDA.gov ↗

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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, 2020-01-01 through 2026-04-23. 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.