Cleared Special

X Sensor (Model: IOS-A15IF, HDI-15DGF)

K242778 · Qpix Solutions, Inc. · Radiology

Oct 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K242778 is an FDA 510(k) clearance for the X Sensor (Model: IOS-A15IF, HDI-15DGF), a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Qpix Solutions, Inc. (Morrisville, US). The FDA issued a Cleared decision on October 11, 2024, 28 days after receiving the submission on September 13, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K242778 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2024
Decision Date	October 11, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF