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FDA 510(k)

MiniCAT 2D

K-Number: K201825 · 2020-11-20

ApplicantXoran Technologies, LLC
Decision Date2020-11-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MiniCAT 2D is a medical device manufactured by Xoran Technologies, LLC. It received FDA 510(k) clearance on 2020-11-20 under approval number K201825. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniCAT 2D?

MiniCAT 2D is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Xoran Technologies, LLC. The 510(k) number is K201825.

When was MiniCAT 2D approved by the FDA?

MiniCAT 2D received FDA 510(k) clearance on 2020-11-20, under approval number K201825.

What company makes MiniCAT 2D?

MiniCAT 2D is manufactured by Xoran Technologies, LLC.

What is the FDA product code for MiniCAT 2D?

The FDA product code for MiniCAT 2D is KPR.

Other Devices by Xoran Technologies, LLC

K210257Xoran Workstation, Model 10050 K221230TRON

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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