FDA 510(k)

X感測器（型號：IOS-A15IF，HDI-15DGF）

K 號：K242778 · 2024-10-11

決定日期2024-10-11

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

X Sensor (Model: IOS-A15IF, HDI-15DGF) is the device name listed in this FDA 510(k) record. The listed applicant is Qpix Solutions, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K242778. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the X Sensor (Model: IOS-A15IF, HDI-15DGF)?

X Sensor (Model: IOS-A15IF, HDI-15DGF) is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Qpix Solutions, Inc.. The 510(k) number is K242778.

When did X Sensor (Model: IOS-A15IF, HDI-15DGF) receive FDA 510(k) clearance?

X Sensor (Model: IOS-A15IF, HDI-15DGF) received FDA 510(k) clearance on 2024-10-11, under 510(k) number K242778.

Who is the listed applicant for X Sensor (Model: IOS-A15IF, HDI-15DGF)?

The FDA 510(k) record lists Qpix Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X Sensor (Model: IOS-A15IF, HDI-15DGF)?

The FDA product code for X Sensor (Model: IOS-A15IF, HDI-15DGF) is MUH.

其他以 Qpix Solutions, Inc. 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。

K252570EzSensor HD，EzSensor UHD K232255EZSensor XHD

相關器械（代碼：MUH）

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。

K251793SOTA雲端智慧感測器（1.5）Sota Cloud Corp.K252570EzSensor HD，EzSensor UHDQpix Solutions, Inc.K250687Cocoon獨立 (DX-7020s)Dexcowin Global, Inc.K251206數位X光牙科DentiMax Pro影像系統Dentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph)；VistaPano S 2.0 (VistaPano S)；ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph)；ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K241649DUO1 和 DUO2Zinnovi, Inc.

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