放射系统挑战X
K号: K202293 · 2020-10-07
广告
器械摘要
Radiographic System Challenge X is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K202293. 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 Radiographic System Challenge X?
Radiographic System Challenge X is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Sedecal., Sa.. The 510(k) number is K202293.
When did Radiographic System Challenge X receive FDA 510(k) clearance?
Radiographic System Challenge X received FDA 510(k) clearance on 2020-10-07, under 510(k) number K202293.
Who is the listed applicant for Radiographic System Challenge X?
The FDA 510(k) record lists Sedecal., Sa. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Radiographic System Challenge X?
The FDA product code for Radiographic System Challenge X 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。
列明Sedecal., Sa.为申报人的其他记录
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。
广告