IC-Flow™成像系统2.0
K号: K243645 · 2025-09-22
广告
器械摘要
IC-Flow™ Imaging System 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Green GmbH. It received FDA 510(k) clearance on 2025-09-22 under 510(k) number K243645. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IC-Flow™ Imaging System 2.0?
IC-Flow™ Imaging System 2.0 is a medical device that received FDA 510(k) clearance on 2025-09-22. The listed applicant is Diagnostic Green GmbH. The 510(k) number is K243645.
When did IC-Flow™ Imaging System 2.0 receive FDA 510(k) clearance?
IC-Flow™ Imaging System 2.0 received FDA 510(k) clearance on 2025-09-22, under 510(k) number K243645.
Who is the listed applicant for IC-Flow™ Imaging System 2.0?
The FDA 510(k) record lists Diagnostic Green GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IC-Flow™ Imaging System 2.0?
The FDA product code for IC-Flow™ Imaging System 2.0 is IZI.
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：IZI）
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。
K261037780 nm SPY便携式手持成像（SPY-PHI）系统Stryker EndoscopyK253181SURGIMAGE SIM 1000H 荧光成像平台Surgimage CorporationK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbHK231075荧光配件（YELLOW 560 和 INFRARED 800 带FLOW 800 选项）Carl Zeiss Meditec, 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