DELL UP3017 with QUBYX PerfectLum Bundle
by Qubyx Software Technologies, Inc.
510(k) K171229
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171229 | Date26 May 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- PGY
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Dell UP3017 with Qubyx PerfectLum Bundle is a Diagnostic Radiology Display designed for medical imaging applications. This device integrates a 30-inch color LCD display with Qubyx PerfectLum software, enabling precise visualization of digital radiographic images. It adheres to industry standards such as DICOM Part 14 GSDF and AAPM TG18 to ensure accurate and compliant image presentation, supporting diagnostic workflows in radiology settings.
The system is supplied as a bundled solution, combining hardware and software for display calibration and verification. It is intended for use in clinical environments where high-fidelity image rendering is critical, such as radiology departments. The device is not described as single-use or reusable, and no sterility or MRI safety information is provided. Authorized for use in the United States under an FDA 510(k) clearance (K171229), it falls under Device Class II (PGY) regulatory classification. Storage and handling instructions are not specified in the available data.
Other devices from Qubyx Software Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Dell UP3017 with Qubyx PerfectLum Bundle used for?
This device is designed for medical imaging applications in radiology settings. It integrates a 30-inch color LCD display with Qubyx PerfectLum software to provide high-fidelity visualization of digital radiographic images, ensuring precise and compliant diagnostic workflows. The bundle supports industry standards like DICOM Part 14 GSDF and AAPM TG18, which are critical for accurate image presentation in clinical environments.
How is the Dell UP3017 with Qubyx PerfectLum Bundle supplied?
The device is supplied as a bundled solution, combining both the Dell UP3017 hardware display and the Qubyx PerfectLum software. This bundle is intended to streamline the setup process for radiology departments, ensuring that the display is pre-configured for calibration and verification of radiographic images. No additional components or separate purchases are required for basic functionality.
Is the Dell UP3017 with Qubyx PerfectLum Bundle single-use or reusable?
The available data does not specify whether the device is single-use or reusable. However, given that it is a hardware-software bundle for diagnostic imaging displays, it is intended for repeated use in clinical settings. The display itself is not described as disposable, and no sterility information is provided, indicating it is designed for ongoing use in radiology workflows.
What are the key specifications or standards this device adheres to?
The Dell UP3017 with Qubyx PerfectLum Bundle adheres to industry standards such as DICOM Part 14 GSDF (Grayscale Standard Display Function) and AAPM TG18 (American Association of Physicists in Medicine Task Group 18). These standards ensure that the display provides accurate and consistent grayscale rendering of radiographic images, which is essential for reliable diagnostic interpretations in radiology.
What regulatory approval does this device hold?
The device is authorized for use in the United States under an FDA 510(k) clearance with the clearance number K171229. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting the regulatory requirements for Class II (PGY) diagnostic radiology displays. The approval ensures compliance with U.S. regulatory standards for medical imaging equipment.