Data / Medical devices / United States / Qpix Solutions, Inc.
Qpix Solutions, Inc.: FDA-registered device maker in Durham, NC, United States, 20 510(k) clearances
Qpix Solutions, Inc. is registered with the FDA (registration 3025442726) in Durham, NC, United States. It lists 8 device types. The FDA files 20 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025442726
- Address
- 2933 S Miami Blvd Ste 119, Durham NC 27703-9041, Durham, NC, United States, 27703
- Owner or operator
- QPIX SOLUTIONS, INC. (10086838)
- Roles
- Repackager or relabeler
- First device listed
- May 22, 2023
- Registered through
- 2026
- Brand names listed
- 0909FCC, 0909FCC-HS, 0909fcb, 1212fca, 1012wcc, 1012wgc, 1212FCA, 1417WCC, 1417WCE, 1417WCE-GF and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | K250976 | Airbile-100 | IZL | Substantially Equivalent | Poskom Co., Ltd. | accessdata.fda.gov |
| March 12, 2025 | K243849 | 2430TCA with Xmaru W | MUE | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| September 9, 2024 | K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| March 7, 2024 | K240371 | 0909FCC, 0909FCC-HS | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| June 21, 2023 | K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| October 18, 2021 | K212753 | 0909FCB, 1212FCA | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| April 28, 2021 | K210985 | 1717FCC | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| October 26, 2020 | K202722 | 1212FCA | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| July 23, 2020 | K201796 | 1717SCV, 1717SGV | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| June 29, 2020 | K201503 | Edge Air(1417) Digital Flat Panel X-ray Detector | MQB | Substantially Equivalent | Osko, Inc. | accessdata.fda.gov |
| October 6, 2017 | K172682 | Edge Digital Flat Panel X-ray Detector | MQB | Substantially Equivalent | Osko, Inc. | accessdata.fda.gov |
| October 6, 2017 | K172681 | Edge Air Digital Flat Panel X-ray Detector | MQB | Substantially Equivalent | Osko, Inc. | accessdata.fda.gov |
| July 28, 2017 | K163048 | Smart Stitching Software System, Image Processing, Radiological | LLZ | Substantially Equivalent | Osko, Inc. | accessdata.fda.gov |
| June 12, 2017 | K171418 | 1417WCC_127um and1417WCC_140um | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| June 12, 2017 | K171417 | 1417WGC_127um and 1417WGC_140um | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| June 9, 2017 | K171420 | 1717SCC_127um and 1717SCC_140um | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| October 6, 2016 | K162519 | 1717WCC / 1717WGC | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| October 6, 2016 | K162518 | 1012WCC, 1012WGC | MQB | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| November 10, 2015 | K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | MUH | Substantially Equivalent | Rayence Co., Ltd. | accessdata.fda.gov |
| June 23, 1981 | K811230 | X-CELL X-RAY #'S P-75W/P-75M | KPR | Substantially Equivalent | X-Cel X-Ray Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Stationary
- All makers of Generator, High-Voltage, X-Ray, Diagnostic
- All makers of System, X-Ray, Mobile
- All makers of System, X-Ray, Extraoral Source, Digital
Updated December 19, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.