FDA 510(k)

DRE Duo

K号: K260482 · 2026-06-15

决定日期2026-06-15

产品代码KPR

咨询委员会RA

决定实质等同

器械摘要

DRE Duo is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260482. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DRE Duo?

DRE Duo is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Jpi Healthcare Co, Ltd.. The 510(k) number is K260482.

When did DRE Duo receive FDA 510(k) clearance?

DRE Duo received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260482.

Who is the listed applicant for DRE Duo?

The FDA 510(k) record lists Jpi Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRE Duo?

The FDA product code for DRE Duo is KPR.

列明Jpi Healthcare 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。

K244010ExamVue Apex K213057ExamVue Duo

相关器械（代码：KPR）

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。

K260227EXSYS DEXi（EXSYS DEXi-S40S）；EXSYS DEXi（EXSYS DEXi-S40P）；EXSYS DEXi（EXSYS DEXi-S40T）；EXSYS DEXi（EXSYS DEXi-S50H）DRTECH Corporation K260488MULTIX Impact；MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X射线系统，DRX-Compass 移动X射线系统，Lux HD 35探测器，Lux HD 43探测器Carestream Health K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.

官方来源

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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。