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

FDA 510(k) K242778 · Qpix Solutions, Inc.

Substantially Equivalent

510(k) numberK242778

Submission

Device name
X Sensor (Model: IOS-A15IF, HDI-15DGF)
Applicant
Qpix Solutions, Inc.
Morrisville, NC, US
Received
September 13, 2024
Decision date
October 11, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUH – System, X-Ray, Extraoral Source, Digital
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1800
Specialty
Dental

Other 510(k)s with product code MUH

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K250687Cocoon Solo (DX-7020s)MUH · Traditional Dexcowin Global, Inc.10/24/2025SE
K251206Digital X-Ray DentiMax Pro Imaging SystemMUH · Traditional Dentimax, Inc.09/24/2025SE
K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan…MUH · Traditional VATECH Co., Ltd.10/25/2024SE
K241649DUO1 and DUO2MUH · Traditional Zinnovi, Inc.07/05/2024SE
K232325RAYSCAN a-ExpertMUH · Traditional Ray Co., Ltd.04/18/2024SE
K231660Digital image scanner of dentalMUH · Traditional Jiangsu Dynamic Medical Technology Co., Ltd.12/20/2023SE
K233053DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2…MUH · Traditional Dental Imaging Technologies Corporation11/21/2023SE
K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)MUH · Abbreviated Tuxedo Imaging, LLC10/20/2023SE

More from Tuxedo Imaging, LLC

510(k)DeviceDecision
K252570EzSensor HD, EzSensor UHDMUH · Special 11/10/2025SE
K232255EZSensor XHDMUH · Traditional 09/27/2023SE

Questions and answers

When was X Sensor (Model: IOS-A15IF, HDI-15DGF) cleared by the FDA?

X Sensor (Model: IOS-A15IF, HDI-15DGF) (K242778) received a 510(k) decision of Substantially Equivalent on October 11, 2024, 28 days after the submission was received.

What is the product code of K242778?

The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.