Mammo Tomosynthesis (MDMG-5221)
K号: K161229 · 2016-05-18
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器械摘要
Mammo Tomosynthesis (MDMG-5221) is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2016-05-18 under 510(k) number K161229. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Mammo Tomosynthesis (MDMG-5221)?
Mammo Tomosynthesis (MDMG-5221) is a medical device that received FDA 510(k) clearance on 2016-05-18. The listed applicant is Barco N.V.. The 510(k) number is K161229.
When did Mammo Tomosynthesis (MDMG-5221) receive FDA 510(k) clearance?
Mammo Tomosynthesis (MDMG-5221) received FDA 510(k) clearance on 2016-05-18, under 510(k) number K161229.
Who is the listed applicant for Mammo Tomosynthesis (MDMG-5221)?
The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mammo Tomosynthesis (MDMG-5221)?
The FDA product code for Mammo Tomosynthesis (MDMG-5221) is PGY.
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Barco N.V.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：PGY）
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。
K262783RadiForce MX247WEizo CorporationK261213医用监护仪（40HT513D）Lg Electronics.IncK252780LCD 显示器 (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD 显示器 (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo Corporation
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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