Discovery XR656 HD X-Ray System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Discovery XR656 HD EUDAMEDDiscovery FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Discovery XR656 HD EUDAMEDDiscovery XR656 HD System FDA UDI
- Model / Reference
- Discovery XR656 HD EUDAMEDXR656 HD FDA UDI
- Description
- Discovery XR656 HD System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682138598 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682138598 EUDAMED
- 510(k) Number
- K172869 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)FDA UDIMQB FDA UDIIZF FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)FDA UDI892.1740 FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Discovery XR656 HD is a stationary, high-definition X-ray imaging system designed for radiologic examinations. It provides detailed radiographic imaging for diagnostic purposes across various anatomical regions, supporting clinical assessments in radiology settings. The system incorporates advanced imaging technology to enhance visualization and diagnostic accuracy for medical professionals.
This device is supplied as a reusable, stationary X-ray system intended for use in radiology departments or imaging centers. It operates under regulatory authorizations including FDA 510K clearance and MDD compliance, adhering to Class II medical device standards. The system requires proper installation, maintenance, and adherence to manufacturer guidelines for safe and effective operation, with no specific sterility requirements noted for the device itself.
Frequently asked questions
What types of medical imaging procedures can the Discovery XR656 HD support in a clinical setting?
The Discovery XR656 HD is a stationary high-definition X-ray imaging system designed for detailed radiographic examinations across various anatomical regions. It is specifically intended for diagnostic radiology, enabling high-resolution imaging to support clinical assessments in areas like orthopedics, cardiology, abdominal studies, and general radiography. Its advanced imaging technology enhances visualization for accurate diagnostic evaluations.
Is the Discovery XR656 HD a single-use or reusable device, and what does this mean for maintenance?
The Discovery XR656 HD is a reusable X-ray imaging system, meaning it is not intended for single-use disposal. As a stationary device, it requires proper installation, regular maintenance, and adherence to manufacturer guidelines to ensure safe and effective operation over time. Maintenance includes routine servicing, calibration, and cleaning to sustain performance and compliance with regulatory standards.
How is the Discovery XR656 HD regulated, and what does this imply for purchasing or using it?
The Discovery XR656 HD holds FDA 510K clearance and complies with the Medical Device Directive (MDD), classifying it as a Class II medical device. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets safety and performance standards. Purchasers or users should ensure the system is installed and operated by trained personnel, following manufacturer instructions and local regulatory requirements.
Does the Discovery XR656 HD require sterilization, and if not, how should it be handled to maintain safety?
The Discovery XR656 HD is not described as a sterile device, so it does not require sterilization procedures. However, since it is a reusable X-ray system, it should be cleaned and maintained according to the manufacturer’s guidelines to prevent contamination and ensure optimal performance. Proper handling includes regular disinfection of accessible surfaces and adherence to infection control protocols in radiology settings.
What should buyers consider when evaluating the regulatory and logistical aspects of implementing this device?
Buyers should confirm that the Discovery XR656 HD aligns with their facility’s regulatory requirements, as it holds FDA 510K clearance and MDD compliance. Logistically, it is a stationary system, so space, electrical infrastructure, and installation support must be accounted for. Additionally, ensure trained personnel are available for operation and maintenance, as the device requires proper setup and ongoing servicing to comply with its Class II classification and manufacturer specifications.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K172869 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Hualun Medical Systems Co., Ltd
- FDA Applicant
- Ge Hualun Medical Systems Co. , Ltd.
Sources (3)
- FDA 510(k) K172869 24 fields · synced Sep 18, 2026
- FDA UDI 29fb5c5a-4db4-4d8b-9164-ade71c6bcfa7 34 fields · synced May 30, 2026
- EUDAMED 1e51c796-af0b-482c-b25f-2b9305999b3a 61 fields · synced Jul 25, 2026