Planmed Clarity 2D, Planmed Clarify S
K号: K211720 · 2022-07-18
广告
器械摘要
Planmed Clarity 2D, Planmed Clarify S is the device name listed in this FDA 510(k) record. The listed applicant is Planmed OY. It received FDA 510(k) clearance on 2022-07-18 under 510(k) number K211720. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Planmed Clarity 2D, Planmed Clarify S?
Planmed Clarity 2D, Planmed Clarify S is a medical device that received FDA 510(k) clearance on 2022-07-18. The listed applicant is Planmed OY. The 510(k) number is K211720.
When did Planmed Clarity 2D, Planmed Clarify S receive FDA 510(k) clearance?
Planmed Clarity 2D, Planmed Clarify S received FDA 510(k) clearance on 2022-07-18, under 510(k) number K211720.
Who is the listed applicant for Planmed Clarity 2D, Planmed Clarify S?
The FDA 510(k) record lists Planmed OY as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Planmed Clarity 2D, Planmed Clarify S?
The FDA product code for Planmed Clarity 2D, Planmed Clarify S is MUE.
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Planmed OY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：MUE）
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。
K254090I-View®Hologic, Inc.K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina；SenoBright HD；Pristina Serena；Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.
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