FDA 510(k)

DRX-Evolution/Plus雙能量

K 號：K190330 · 2019-11-04

決定日期2019-11-04

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

DRX-Evolution/Plus with Dual Energy 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 2019-11-04 under 510(k) number K190330. 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/Plus with Dual Energy?

DRX-Evolution/Plus with Dual Energy is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Carestream Health, Inc.. The 510(k) number is K190330.

When did DRX-Evolution/Plus with Dual Energy receive FDA 510(k) clearance?

DRX-Evolution/Plus with Dual Energy received FDA 510(k) clearance on 2019-11-04, under 510(k) number K190330.

Who is the listed applicant for DRX-Evolution/Plus with Dual Energy?

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/Plus with Dual Energy?

The FDA product code for DRX-Evolution/Plus with Dual Energy is KPR.

其他以 Carestream Health, Inc. 為申請人之記錄

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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 Corporation K260488MULTIX 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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