FDA 510(k)

超輕便型X光機

K 號：K232068 · 2023-09-01

申請人Changzhou Sifary Medical Technology Co., Ltd.

決定日期2023-09-01

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

HyperLight Portable X-ray Unit is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K232068. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HyperLight Portable X-ray Unit?

HyperLight Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K232068.

When did HyperLight Portable X-ray Unit receive FDA 510(k) clearance?

HyperLight Portable X-ray Unit received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232068.

Who is the listed applicant for HyperLight Portable X-ray Unit?

FDA 510(k) 記錄將常州市思法瑞醫療科技有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for HyperLight Portable X-ray Unit?

The FDA product code for HyperLight Portable X-ray Unit is EHD.

其他以 Changzhou Sifary Medical Technology Co., Ltd. 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。

K260795手持式牙科X光系統（HyperLight-M）K252224Apex 定位器 (FindPex)K221152治療筆牙科固化燈 K201993E-connect S 結腸電動機，內建 Apex 定位器

相關器械（代碼：EHD）

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。

K260795手持式牙科X光系統（HyperLight-M）Changzhou Sifary Medical Technology Co., Ltd.K260367可攜式牙科X光系統型號 PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies Corporation K252110牙科X光單元（AJX200）Guangzhou Ajax Medical Equipment Co., Ltd.K254018攜帶式牙科X光設備（GT-1）Guilin Refine Medical Instrument Co., Ltd.K252909診斷X光設備型號 POCT22Ningbo Runyes Medical Instrument Co., Ltd.

官方來源

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