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FDA 510(k)

INNOVISION-EXII

K 號：K242119 · 2025-01-03

申請人Dk Medical System
決定日期2025-01-03
產品代碼KPR
諮詢委員會RA
決定相當於

器材摘要

INNOVISION-EXII is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medical System. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K242119. 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 INNOVISION-EXII?

INNOVISION-EXII is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Dk Medical System. The 510(k) number is K242119.

When did INNOVISION-EXII receive FDA 510(k) clearance?

INNOVISION-EXII received FDA 510(k) clearance on 2025-01-03, under 510(k) number K242119.

Who is the listed applicant for INNOVISION-EXII?

The FDA 510(k) record lists Dk Medical System as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVISION-EXII?

The FDA product code for INNOVISION-EXII is KPR.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 CorporationK260488MULTIX 震擊；MULTIX 震擊 CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE 雙用設備Jpi Healthcare 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

官方來源

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