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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 the device name listed in this FDA 510(k) record. The listed applicant is Xoran Technologies, LLC. It received FDA 510(k) clearance on 2020-11-20 under 510(k) 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. The listed applicant is Xoran Technologies, LLC. The 510(k) number is K201825.

When did MiniCAT 2D receive FDA 510(k) clearance?

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

Who is the listed applicant for MiniCAT 2D?

The FDA 510(k) record lists Xoran Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiniCAT 2D?

The FDA product code for MiniCAT 2D is KPR.

Other records listing Xoran Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221230TRONK210257Xoran Workstation, Model 10050

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream HealthK252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.K250788Definium Tempo SelectGe Hualun Medical Systems Co. , Ltd.

Official Source

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

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