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510(k) K232255

EZSensor XHD by Qpix Solutions, Inc. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
July 28, 2023
Clearance Type
Traditional
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

Other clearances by Qpix Solutions, Inc.

  • K252570 — EzSensor HD, EzSensor UHD (November 10, 2025)
  • K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF) (October 11, 2024)

Other clearances for product code MUH

  • K251793 — SOTA Cloud Smart Sensor (1.5) (March 3, 2026)
  • K252570 — EzSensor HD, EzSensor UHD (November 10, 2025)
  • K250687 — Cocoon Solo (DX-7020s) (October 24, 2025)
  • K251206 — Digital X-Ray DentiMax Pro Imaging System (September 24, 2025)
  • K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta (October 25, 2024)
  • K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF) (October 11, 2024)
  • K241649 — DUO1 and DUO2 (July 5, 2024)
  • K232325 — RAYSCAN a-Expert (April 18, 2024)
  • K231660 — Digital image scanner of dental (December 20, 2023)
  • K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 (November 21, 2023)