FDA 510(k)

SKANRAD 400

K 號：K220518 · 2022-04-01

決定日期2022-04-01

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

SKANRAD 400 is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Limited. It received FDA 510(k) clearance on 2022-04-01 under 510(k) number K220518. 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 SKANRAD 400?

SKANRAD 400 is a medical device that received FDA 510(k) clearance on 2022-04-01. The listed applicant is Skanray Technologies Limited. The 510(k) number is K220518.

When did SKANRAD 400 receive FDA 510(k) clearance?

SKANRAD 400 received FDA 510(k) clearance on 2022-04-01, under 510(k) number K220518.

Who is the listed applicant for SKANRAD 400?

The FDA 510(k) record lists Skanray Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKANRAD 400?

The FDA product code for SKANRAD 400 is KPR.

其他以 Skanray Technologies Limited 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。

K251893SKAN C PULSAR K231761PodSKAN HF 體掃斷層X光系統 K212940Skanmobile, Skanmobile-Dr

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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