玉山X射线平板探测器
K号: K250211 · 2025-07-22
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器械摘要
Yushan X-Ray Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Innocare Optoelectronics Corp.. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K250211. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Yushan X-Ray Flat Panel Detector?
Yushan X-Ray Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Innocare Optoelectronics Corp.. The 510(k) number is K250211.
When did Yushan X-Ray Flat Panel Detector receive FDA 510(k) clearance?
Yushan X-Ray Flat Panel Detector received FDA 510(k) clearance on 2025-07-22, under 510(k) number K250211.
Who is the listed applicant for Yushan X-Ray Flat Panel Detector?
The FDA 510(k) record lists Innocare Optoelectronics Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Yushan X-Ray Flat Panel Detector?
The FDA product code for Yushan X-Ray Flat Panel Detector is MQB.
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Innocare Optoelectronics Corp.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：MQB）
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。
K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 探测器 (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250665SKR 3000Konica Minolta, Inc.K243734无线/有线X射线平板探测器Allengers Medical Systems Limited
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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