VFSS Pro 移动数字成像系统
K号: K212523 · 2021-11-05
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器械摘要
VFSS Pro Mobile Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Imagexray, LLC. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212523. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VFSS Pro Mobile Digital Imaging System?
VFSS Pro Mobile Digital Imaging System is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Imagexray, LLC. The 510(k) number is K212523.
When did VFSS Pro Mobile Digital Imaging System receive FDA 510(k) clearance?
VFSS Pro Mobile Digital Imaging System received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212523.
Who is the listed applicant for VFSS Pro Mobile Digital Imaging System?
The FDA 510(k) record lists Imagexray, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VFSS Pro Mobile Digital Imaging System?
The FDA product code for VFSS Pro Mobile Digital Imaging System is OWB.
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：OWB）
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。
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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