780 nm SPY便携式手持成像（SPY-PHI）系统
K号: K261037 · 2026-05-28
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器械摘要
780 nm SPY Portable Handheld Imaging (SPY-PHI) System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K261037. 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 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?
780 nm SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Stryker Endoscopy. The 510(k) number is K261037.
When did 780 nm SPY Portable Handheld Imaging (SPY-PHI) System receive FDA 510(k) clearance?
780 nm SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K261037.
Who is the listed applicant for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?
FDA 510(k)记录显示Stryker Endoscopy为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System?
The FDA product code for 780 nm SPY Portable Handheld Imaging (SPY-PHI) System 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。
列明Stryker Endoscopy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：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。
K253181SURGIMAGE SIM 1000H 荧光成像平台Surgimage CorporationK243645IC-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。
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