FDA 510(k)

加里安影像強化式X光攝影系統，移動式

K 號：K222080 · 2022-10-06

決定日期2022-10-06

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Sg Healthcare Co, Ltd.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K222080. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Sg Healthcare Co, Ltd.. The 510(k) number is K222080.

When did Garion Image-Intensified Fluoroscopic X-Ray System, Mobile receive FDA 510(k) clearance?

Garion Image-Intensified Fluoroscopic X-Ray System, Mobile received FDA 510(k) clearance on 2022-10-06, under 510(k) number K222080.

Who is the listed applicant for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

The FDA 510(k) record lists Sg Healthcare Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile?

The FDA product code for Garion Image-Intensified Fluoroscopic X-Ray System, Mobile is OWB.

其他以 Sg Healthcare Co, Ltd. 為申請人之記錄

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K230241朱蒙通用

相關器械（代碼：OWB）

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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官方來源

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