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FDA 510(k)

OPTIS 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)

K号: K253459 · 2026-04-24

申请人ABBOTT MEDICAL
决定日期2026-04-24
产品代码NQQ
咨询委员会RA
决定实质等同

器械摘要

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K253459. 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 OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)?

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K253459.

When did OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) receive FDA 510(k) clearance?

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) received FDA 510(k) clearance on 2026-04-24, under 510(k) number K253459.

Who is the listed applicant for OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)?

The FDA product code for OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明ABBOTT MEDICAL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。

K261729EnSite™ X EP系统K262006EnSite™ X EP系统K261631Amplatzer TorqVue 交换系统K260212EnSite™ X EP系统K253907一次性射频消融电极K260499Amplatzer™ Trevisio™ 血管内输送系统；9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

查看所有 60 个设备 →

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。

K251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™成像系统 - 集成Spectrawave, 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 →

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