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FDA 510(k)

EzSensor HD

K-Number: K261663 · 2026-09-30

ApplicantQpix Solutions, Inc.
Decision Date2026-09-30
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EzSensor HD 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 2026-09-30 under 510(k) number K261663. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EzSensor HD?

EzSensor HD is a medical device that received FDA 510(k) clearance on 2026-09-30. The listed applicant is Qpix Solutions, Inc.. The 510(k) number is K261663.

When did EzSensor HD receive FDA 510(k) clearance?

EzSensor HD received FDA 510(k) clearance on 2026-09-30, under 510(k) number K261663.

Who is the listed applicant for EzSensor HD?

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 EzSensor HD?

The FDA product code for EzSensor HD is MUH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Qpix Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252570EzSensor HD, EzSensor UHDK242778X Sensor (Model: IOS-A15IF, HDI-15DGF)K232255EZSensor XHD

Related Devices (Code: MUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, 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.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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