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FDA 510(k)

X Sensor (Model: IOS-A15IF, HDI-15DGF)

K-Number: K242778 · 2024-10-11

ApplicantQpix Solutions, Inc.
Decision Date2024-10-11
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X Sensor (Model: IOS-A15IF, HDI-15DGF) 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 2024-10-11 under 510(k) number K242778. 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 X Sensor (Model: IOS-A15IF, HDI-15DGF)?

X Sensor (Model: IOS-A15IF, HDI-15DGF) is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Qpix Solutions, Inc.. The 510(k) number is K242778.

When did X Sensor (Model: IOS-A15IF, HDI-15DGF) receive FDA 510(k) clearance?

X Sensor (Model: IOS-A15IF, HDI-15DGF) received FDA 510(k) clearance on 2024-10-11, under 510(k) number K242778.

Who is the listed applicant for X Sensor (Model: IOS-A15IF, HDI-15DGF)?

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 X Sensor (Model: IOS-A15IF, HDI-15DGF)?

The FDA product code for X Sensor (Model: IOS-A15IF, HDI-15DGF) 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.

K252570EzSensor HD, EzSensor UHDK232255EZSensor 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.K241649DUO1 and DUO2Zinnovi, 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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