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FDA 510(k)

OTIS 2.1 光相干断层扫描系统，THiA 光相干断层扫描系统

K号: K203578 · 2021-02-25

申请人Perimeter Medical Imaging Ai, Inc.
决定日期2021-02-25
产品代码NQQ
咨询委员会RA
决定实质等同

器械摘要

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging Ai, Inc.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203578. 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 OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Perimeter Medical Imaging Ai, Inc.. The 510(k) number is K203578.

When did OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System receive FDA 510(k) clearance?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203578.

Who is the listed applicant for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

The FDA 510(k) record lists Perimeter Medical Imaging Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

The FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography 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。

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

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.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 Plant

官方来源

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