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FDA 510(k)

FS-500DDR Medical Radiographic X-Ray System

K-Number: K152813 · 2016-12-02

ApplicantOrich Medical Equipment (Tianjin) Co., Ltd.
Decision Date2016-12-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FS-500DDR Medical Radiographic X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Orich Medical Equipment (Tianjin) Co., Ltd.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K152813. 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 FS-500DDR Medical Radiographic X-Ray System?

FS-500DDR Medical Radiographic X-Ray System is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Orich Medical Equipment (Tianjin) Co., Ltd.. The 510(k) number is K152813.

When did FS-500DDR Medical Radiographic X-Ray System receive FDA 510(k) clearance?

FS-500DDR Medical Radiographic X-Ray System received FDA 510(k) clearance on 2016-12-02, under 510(k) number K152813.

Who is the listed applicant for FS-500DDR Medical Radiographic X-Ray System?

The FDA 510(k) record lists Orich Medical Equipment (Tianjin) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FS-500DDR Medical Radiographic X-Ray System?

The FDA product code for FS-500DDR Medical Radiographic X-Ray System is KPR.

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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