手部诊断放射摄影成像系统
K号: K220271 · 2022-04-29
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器械摘要
Hand Diagnostic Radiography Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Nanoray Biotech Co., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220271. 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 Hand Diagnostic Radiography Imaging System?
Hand Diagnostic Radiography Imaging System is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Nanoray Biotech Co., Ltd.. The 510(k) number is K220271.
When did Hand Diagnostic Radiography Imaging System receive FDA 510(k) clearance?
Hand Diagnostic Radiography Imaging System received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220271.
Who is the listed applicant for Hand Diagnostic Radiography Imaging System?
The FDA 510(k) record lists Nanoray Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hand Diagnostic Radiography Imaging System?
The FDA product code for Hand Diagnostic Radiography Imaging System is KPR.
相关临床试验
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。
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。
K260227EXSYS DEXi（EXSYS DEXi-S40S）；EXSYS DEXi（EXSYS DEXi-S40P）；EXSYS DEXi（EXSYS DEXi-S40T）；EXSYS DEXi（EXSYS DEXi-S50H）DRTECH CorporationK260488MULTIX Impact；MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X射线系统，DRX-Compass 移动X射线系统，Lux HD 35探测器，Lux HD 43探测器Carestream Health
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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