FDA 510(k)

EXPD 114；EXPD 114G；EXPD 114P；EXPD 114PG

K 號：K242770 · 2025-03-20

決定日期2025-03-20

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG is the device name listed in this FDA 510(k) record. The listed applicant is DRTECH Corporation. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K242770. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG?

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is DRTECH Corporation. The 510(k) number is K242770.

When did EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG receive FDA 510(k) clearance?

EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG received FDA 510(k) clearance on 2025-03-20, under 510(k) number K242770.

Who is the listed applicant for EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG?

FDA 510(k) 記錄將 DRTECH Corporation 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG?

The FDA product code for EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG is MQB.

其他以 DRTECH Corporation 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。

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相關器械（代碼：MQB）

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。

K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) Limited K250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

官方來源

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