iQFlex Pro
K号: K240009 · 2024-07-03
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器械摘要
iQFlex Pro is the device name listed in this FDA 510(k) record. The listed applicant is First Source, Inc.. It received FDA 510(k) clearance on 2024-07-03 under 510(k) number K240009. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iQFlex Pro?
iQFlex Pro is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is First Source, Inc.. The 510(k) number is K240009.
When did iQFlex Pro receive FDA 510(k) clearance?
iQFlex Pro received FDA 510(k) clearance on 2024-07-03, under 510(k) number K240009.
Who is the listed applicant for iQFlex Pro?
The FDA 510(k) record lists First Source, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iQFlex Pro?
The FDA product code for iQFlex Pro is IZL.
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First Source, Inc.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：IZL）
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。
K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058便携式DR成像系统Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO 移动X光系统（型号：RAYMO）DRGEM CorporationK253185Lux HD 探测器，DRX-LC 探测器，DRX-Revolution 移动X射线系统Carestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F（AirRay-mini）Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.
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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