1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
K号: K231467 · 2023-06-21
广告
器械摘要
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K231467. 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 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K231467.
When did 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF receive FDA 510(k) clearance?
1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231467.
Who is the listed applicant for 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?
FDA 510(k)记录将Rayence Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF?
The FDA product code for 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF is MQB.
列明Rayence 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。
广告