固态 X 射线成像仪（型号：FXRD-4386WB）
K号: K220239 · 2022-09-13
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器械摘要
Solid State X-ray Imager(Model: FXRD-4386WB) is the device name listed in this FDA 510(k) record. The listed applicant is Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K220239. 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 Solid State X-ray Imager(Model: FXRD-4386WB)?
Solid State X-ray Imager(Model: FXRD-4386WB) is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Vieworks Co., Ltd.. The 510(k) number is K220239.
When did Solid State X-ray Imager(Model: FXRD-4386WB) receive FDA 510(k) clearance?
Solid State X-ray Imager(Model: FXRD-4386WB) received FDA 510(k) clearance on 2022-09-13, under 510(k) number K220239.
Who is the listed applicant for Solid State X-ray Imager(Model: FXRD-4386WB)?
The FDA 510(k) record lists Vieworks Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Solid State X-ray Imager(Model: FXRD-4386WB)?
The FDA product code for Solid State X-ray Imager(Model: FXRD-4386WB) 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Vieworks Co., Ltd.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) LimitedK250211玉山X射线平板探测器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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