FDA 510(k)

DRE 雙用設備

K 號：K260482 · 2026-06-15

決定日期2026-06-15

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Jpi Healthcare Co, Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K244010ExamVue Apex K213057ExamVue 雙用設備

相關器械（代碼：KPR）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260227EXSYS DEXi (EXSYS DEXi-S40S)；EXSYS DEXi (EXSYS DEXi-S40P)；EXSYS DEXi (EXSYS DEXi-S40T)；EXSYS DEXi (EXSYS DEXi-S50H)DRTECH Corporation K260488MULTIX 震擊；MULTIX 震擊 CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus 電影系統，DRX-Compass 流動電影系統，Lux HD 35 探測器，Lux HD 43 探測器Carestream Health K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.

官方來源

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