X9 超声系统
K号: K251673 · 2025-10-17
广告
器械摘要
X9 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is X9, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251673. The device is classified under product code SGH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the X9 Ultrasound System?
X9 Ultrasound System is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is X9, Inc.. The 510(k) number is K251673.
When did X9 Ultrasound System receive FDA 510(k) clearance?
X9 Ultrasound System received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251673.
Who is the listed applicant for X9 Ultrasound System?
The FDA 510(k) record lists X9, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X9 Ultrasound System?
The FDA product code for X9 Ultrasound System is SGH.
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。
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