SURGIMAGE SIM 1000H 荧光成像平台
K号: K253181 · 2026-05-13
广告
器械摘要
SURGIMAGE SIM 1000H Fluorescence Imaging Platform is the device name listed in this FDA 510(k) record. The listed applicant is Surgimage Corporation. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K253181. 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 SURGIMAGE SIM 1000H Fluorescence Imaging Platform?
SURGIMAGE SIM 1000H Fluorescence Imaging Platform is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Surgimage Corporation. The 510(k) number is K253181.
When did SURGIMAGE SIM 1000H Fluorescence Imaging Platform receive FDA 510(k) clearance?
SURGIMAGE SIM 1000H Fluorescence Imaging Platform received FDA 510(k) clearance on 2026-05-13, under 510(k) number K253181.
Who is the listed applicant for SURGIMAGE SIM 1000H Fluorescence Imaging Platform?
The FDA 510(k) record lists Surgimage Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SURGIMAGE SIM 1000H Fluorescence Imaging Platform?
The FDA product code for SURGIMAGE SIM 1000H Fluorescence Imaging Platform 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 EndoscopyK243645IC-Flow™成像系统2.0Diagnostic Green GmbHK243077Affirm 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