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FDA 510(k)

DRX-Evolution 配合 Carestream 電子斷層掃描

K 號：K191879 · 2019-12-20

申請人Carestream Health, Inc.
決定日期2019-12-20
產品代碼KPR
諮詢委員會RA
決定相當於

器材摘要

DRX-Evolution with Carestream Digital Tomosynthesis is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191879. 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 DRX-Evolution with Carestream Digital Tomosynthesis?

DRX-Evolution with Carestream Digital Tomosynthesis is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Carestream Health, Inc.. The 510(k) number is K191879.

When did DRX-Evolution with Carestream Digital Tomosynthesis receive FDA 510(k) clearance?

DRX-Evolution with Carestream Digital Tomosynthesis received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191879.

Who is the listed applicant for DRX-Evolution with Carestream Digital Tomosynthesis?

The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRX-Evolution with Carestream Digital Tomosynthesis?

The FDA product code for DRX-Evolution with Carestream Digital Tomosynthesis 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。

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其他以 Carestream Health, Inc. 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。

K251168影像套件K241505DRX-革命型移動X光系統K233381DRX-Evolution Plus 系統K223842DRX - 磁羅盤K213307Eclipse II 智能噪音消除器K202441Eclipse II 智能噪音消除器

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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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