510(k) K252570

EzSensor HD, EzSensor UHD by Qpix Solutions, Inc. — Product Code MUH

K252570 is an FDA 510(k) premarket notification submitted by Qpix Solutions, Inc. for the device "EzSensor HD, EzSensor UHD". The FDA issued a decision of Substantially Equivalent on November 10, 2025. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Qpix Solutions, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2025
Date Received
August 14, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type