MiniCAT 2D— 510(k) K201825

Name: FDA 510(k) clearance K201825
Creator: U.S. Food and Drug Administration
Published: 2020-11-20

Substantially Equivalent

Xoran Technologies, LLC

FDA 510(k) clearance K201825 for MiniCAT 2D, Substantially Equivalent on 2020-11-20. Applicant: Xoran Technologies, LLC. Device class: 2.

Clearance details

Applicant: Xoran Technologies, LLC
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-07-02
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.