MRJ 3300— 510(k) K122034

Name: FDA 510(k) clearance K122034
Creator: U.S. Food and Drug Administration
Published: 2012-12-06

Substantially Equivalent

Paramed S.R.L.

FDA 510(k) clearance K122034 for MRJ 3300, Substantially Equivalent on 2012-12-06. Applicant: Paramed S.R.L.. Device class: 2.

Clearance details

Applicant: Paramed S.R.L.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2012-07-11
Decision date: 2012-12-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Genoa, IT

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.