HyperVue™成像系统 - 集成
K号: K253101 · 2025-12-15
广告
器械摘要
HyperVue™ Imaging System - Integrated is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K253101. 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 HyperVue™ Imaging System - Integrated?
HyperVue™ Imaging System - Integrated is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Spectrawave, Inc.. The 510(k) number is K253101.
When did HyperVue™ Imaging System - Integrated receive FDA 510(k) clearance?
HyperVue™ Imaging System - Integrated received FDA 510(k) clearance on 2025-12-15, under 510(k) number K253101.
Who is the listed applicant for HyperVue™ Imaging System - Integrated?
The FDA 510(k) record lists Spectrawave, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HyperVue™ Imaging System - Integrated?
The FDA product code for HyperVue™ Imaging System - Integrated 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。
列明Spectrawave, Inc.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：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。
K253459OPTIS 移动 Next 成像系统 (1014932)；OPTIS 集成 Next 成像系统 (1014933)；Ultreon 3.0 软件升级套件 (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K252851deepLive（OSP12 + DMS）Damae MedicalK251198HyperVue™软件Spectrawave, Inc.K250684OPUSWAVE 双传感器成像系统Terumo Cardiovascular Systems Thi PlantK242924OPXION 光学皮肤观察器 (OPXSV1-01F)Opxion Technology, Inc.
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