Manufacturer registered with FDA
Qpix Solutions, Inc.
Morrisville, NC, United States. Lists 1 dental device type with FDA across 2 registered establishments, and holds 4 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 5
- 510(k) clearances
- 42023–2026
- Markets registered in
- 1United States
- Establishments
- 2United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Qpix Solutions, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | EzSensor HD (IOS-U10IF)EzSensor HD (IOS-U15IF)EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF)EzSensor HD (IOS-U20IF)X Sensor UHD | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Qpix Solutions, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Sep 2026 | K261663 | EzSensor HD | MUH Digital Extraoral Source X-Ray System |
| 10 Nov 2025 | K252570 | EzSensor HD, EzSensor UHD | MUH Digital Extraoral Source X-Ray System |
| 11 Oct 2024 | K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | MUH Digital Extraoral Source X-Ray System |
| 27 Sep 2023 | K232255 | EZSensor XHD | MUH Digital Extraoral Source X-Ray System |
Also lists devices cleared under other names
Qpix Solutions, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Rayence Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 Nov 2015 | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | Rayence Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| QPIX SOLUTIONS, INC.FDA reg. 3025442726 | Durham, NC, United States | Repacker / relabeler |
| QPIX SOLUTIONS, INC.FDA reg. 3042046320 | Morrisville, NC, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086838). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.