OPUSWAVE 双传感器成像系统
K号: K250684 · 2025-07-02
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器械摘要
OPUSWAVE Dual Sensor Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Thi Plant. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250684. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OPUSWAVE Dual Sensor Imaging System?
OPUSWAVE Dual Sensor Imaging System is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Terumo Cardiovascular Systems Thi Plant. The 510(k) number is K250684.
When did OPUSWAVE Dual Sensor Imaging System receive FDA 510(k) clearance?
OPUSWAVE Dual Sensor Imaging System received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250684.
Who is the listed applicant for OPUSWAVE Dual Sensor Imaging System?
The FDA 510(k) record lists Terumo Cardiovascular Systems Thi Plant as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OPUSWAVE Dual Sensor Imaging System?
The FDA product code for OPUSWAVE Dual Sensor Imaging System is NQQ.
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：NQQ）
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。
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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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