Identifiers
- 510(k) Number
- K252000 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 Arria and uDR Aris are stationary X-ray systems designed for digital radiography. These devices provide high-resolution imaging for diagnostic purposes, enabling radiologists to capture detailed images of internal structures for assessment and treatment planning in radiology settings.
Supplied as reusable medical devices, the uDR Arria and uDR Aris are intended for use in clinical environments where sterile conditions may be required for specific procedures. They are classified as Class II devices under FDA regulations and have received FDA 510(k) clearance, along with compliance under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The systems are manufactured by Shanghai United Imaging Healthcare Co., Ltd., and include multiple registration numbers for regulatory tracking.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252000 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K252000 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 10, 2026