Identifiers
- 510(k) Number
- K192293 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The uDR 592h and uDR 596i are digital radiography systems designed for stationary X-ray imaging. These devices convert X-ray energy from the tube assembly into digital signals via flat-panel detectors, enabling high-resolution radiographic imaging for diagnostic purposes in radiology settings.
These systems are intended for use in clinical environments, supplied as reusable medical devices, and are classified as Class II under FDA regulations. The uDR 592h features a floor-mounted design with an automatic tube-detector system and built-in detector charging, while the uDR 596i offers flexible manual steering for multi-patient examinations. Both models have received FDA 510(k) clearance and comply with the Medical Device Directive (MDD).
Frequently asked questions
What are the key differences between the uDR 592h and uDR 596i models in terms of their design and functionality?
The uDR 592h features a floor-mounted design with an automatic tube-detector system, meaning the detector and X-ray tube move together seamlessly for imaging. It also includes built-in detector charging, simplifying setup. In contrast, the uDR 596i offers manual steering flexibility, allowing operators to adjust positioning for multi-patient examinations without the need for an automated system. Both models are stationary X-ray systems but cater to different workflow needs—automation for efficiency in the 592h versus adaptability in the 596i.
Are these devices single-use or reusable, and what does that mean for maintenance and cleaning?
The uDR 592h and uDR 596i are reusable medical devices, meaning they are designed for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. Since they are stationary systems with mechanical and electronic components, adherence to manufacturer guidelines for cleaning protocols, calibration, and servicing is essential to ensure performance, safety, and compliance with regulatory standards like the FDA’s 510(k) clearance.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
Both the uDR 592h and uDR 596i have undergone FDA 510(k) clearance, confirming they are substantially equivalent to a legally marketed predicate device. Additionally, they comply with the Medical Device Directive (MDD) in Europe. This means they meet U.S. and EU safety, performance, and effectiveness requirements for stationary X-ray systems in radiology, allowing their use in clinical environments where such imaging is standard. The clearance also implies third-party validation of their design and manufacturing processes.
How are these systems supplied, and what should clinicians consider when ordering or integrating them into their facility?
The uDR 592h and uDR 596i are supplied as complete stationary X-ray imaging systems, including the detector, tube assembly, and necessary mounting hardware. Clinicians should consider floor space requirements (floor-mounted for 592h vs. manual steering flexibility for 596i), electrical power needs, and integration with existing PACS (Picture Archiving and Communication Systems) for seamless workflow. Since they are reusable, facilities must also account for maintenance contracts and training for staff to ensure proper operation and compliance with regulatory standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: uDR 592h, uDR 596i (K181413) — FDA 510(k) | Innolitics, K192293 - uDR 592h, uDR 596i - Radiology - 510kdatabase.net, uDR 592h (HD Floor Mounted DR) | United-Imaging Healthcare, uDR 592h, uDR 596i (K192293) — FDA 510 (k) | Innolitics, PDF Shanghai United Imaging Healthcare Co., Ltd. September 12, 2019 Jiading ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K192293 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K192293 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026