SonialVision G4
K号: K190373 · 2019-03-15
广告
器械摘要
SonialVision G4 is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Corporation. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K190373. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SonialVision G4?
SonialVision G4 is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Shimadzu Corporation. The 510(k) number is K190373.
When did SonialVision G4 receive FDA 510(k) clearance?
SonialVision G4 received FDA 510(k) clearance on 2019-03-15, under 510(k) number K190373.
Who is the listed applicant for SonialVision G4?
The FDA 510(k) record lists Shimadzu Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SonialVision G4?
The FDA product code for SonialVision G4 is JAA.
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Shimadzu Corporation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：JAA）
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。
K253103Nexus DRF 数字X射线成像系统Varex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT 移动荧光透视系统Dornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH
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