EzSensor HD— 510(k) K261663
Substantially EquivalentQpix Solutions, Inc.
FDA 510(k) clearance K261663 for EzSensor HD, Substantially Equivalent on 2026-09-30. Applicant: Qpix Solutions, Inc.. Device class: 2.
Summary
EzSensor HD is filed under MUH, digital extraoral source X-ray systems, a dental imaging code. The record doesn't say more about the device than its name and code, so its exact role in the imaging chain isn't spelled out here.
Class II, 21 CFR 872.1800. The record lists Dental as the advisory panel and Radiology as the review panel. It was a Traditional 510(k).
Qpix Solutions, Inc. filed from Morrisville, North Carolina. The clock ran 133 days (May 20 to September 30, 2026).
Clearance details
- Applicant
- Qpix Solutions, Inc.
- Product code
- Product code MUH
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
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