FDA 510(k)

健康X光檢查

K 號：K192320 · 2019-11-26

決定日期2019-11-26

產品代碼QFM

諮詢委員會RA

決定相當於

器材摘要

HealthCXR is the device name listed in this FDA 510(k) record. The listed applicant is Zebra Medical Vision, Ltd.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192320. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HealthCXR?

HealthCXR is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Zebra Medical Vision, Ltd.. The 510(k) number is K192320.

When did HealthCXR receive FDA 510(k) clearance?

HealthCXR received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192320.

Who is the listed applicant for HealthCXR?

The FDA 510(k) record lists Zebra Medical Vision, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HealthCXR?

The FDA product code for HealthCXR is QFM.

其他以 Zebra Medical Vision, Ltd. 為申請人之記錄

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K211803健康PPT K210085健康CCSng K202487健康關節 K200905健康乳攝 K192901健康VCF K190424健康ICH

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相關器械（代碼：QFM）

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。

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482科格奈特AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-Ai K243808Rayvolve PTX-PE 医療設備規範文本 Rayvolve PTX-PE 医療器材規範文本AZmed K243548簡易病例分類Aidoc Medical , Ltd.

官方來源

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