FS-500DDR 医学放射学X射线系统
K号: K152813 · 2016-12-02
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器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：KPR）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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