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FDA 510(k)

EzSensor HD, EzSensor UHD

K-Number: K252570 · 2025-11-10

ApplicantQpix Solutions, Inc.
Decision Date2025-11-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EzSensor HD, EzSensor UHD 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 2025-11-10 under 510(k) number K252570. 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 UHD?

EzSensor HD, EzSensor UHD is a medical device that received FDA 510(k) clearance on 2025-11-10. The listed applicant is Qpix Solutions, Inc.. The 510(k) number is K252570.

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

EzSensor HD, EzSensor UHD received FDA 510(k) clearance on 2025-11-10, under 510(k) number K252570.

Who is the listed applicant for EzSensor HD, EzSensor UHD?

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, EzSensor UHD?

The FDA product code for EzSensor HD, EzSensor UHD is MUH.

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.

K242778X 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.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.K241649DUO1 and DUO2Zinnovi, Inc.

Official Source

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

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