Optima XR646 HD
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Optima XR646 EUDAMEDOptima FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Optima XR646 EUDAMEDXR646 SYS Cabinet UDI FDA UDI
- Model / Reference
- Optima XR646 EUDAMEDXR646 FDA UDI
- Description
- XR646 SYS Cabinet UDI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682115339 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682115339 EUDAMED
- FDA Product Code
- KPR FDA 510(k)FDA UDIMQB 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 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 Optima XR646 HD is a stationary X-ray imaging system designed for high-resolution radiography. It is classified as a radiology device, providing detailed diagnostic imaging for clinical evaluation of internal structures, bones, and soft tissues in various medical settings.
This device is supplied as a reusable medical system and is intended for use in radiology departments. It operates under FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for stationary X-ray systems. The system is not indicated for MRI environments and must be stored and maintained according to manufacturer guidelines to ensure proper functionality and safety.
Frequently asked questions
What types of medical settings is the Optima XR646 HD intended for use in?
The Optima XR646 HD is designed specifically for radiology departments where high-resolution radiography is required. It is intended for detailed imaging of internal structures, bones, and soft tissues in clinical settings where stationary X-ray imaging is necessary. This includes general hospitals, specialized diagnostic centers, and outpatient radiology clinics.
Is the Optima XR646 HD a single-use or reusable device, and what does this mean for maintenance?
The Optima XR646 HD is a reusable medical system, meaning it is built to be used repeatedly after proper cleaning, disinfection, and maintenance. Since it is not disposable, it must be serviced according to the manufacturer’s guidelines to ensure safety, functionality, and compliance with regulatory standards. This includes scheduled inspections, part replacements, and adherence to manufacturer-provided maintenance protocols.
How is the regulatory status of the Optima XR646 HD defined, and what does this imply for purchasing or use?
The Optima XR646 HD holds FDA 510(k) clearance and MDD authorization, confirming it meets regulatory requirements for stationary X-ray imaging systems in the U.S. and EU markets, respectively. This implies the device has undergone rigorous review for safety and performance, but purchasers or users should verify local compliance requirements (e.g., installation, training, and maintenance) to ensure proper integration into their facility. The device is not intended for MRI environments, which requires additional precautions during setup.
What should buyers or clinicians consider regarding storage and environmental conditions for the Optima XR646 HD?
The Optima XR646 HD must be stored and maintained according to the manufacturer’s guidelines to preserve functionality and safety. While the data does not specify exact environmental conditions, stationary X-ray systems like this typically require protection from extreme temperatures, humidity, and physical damage. Buyers should ensure the device is placed in a dedicated radiology space with proper ventilation, electrical grounding, and access to maintenance resources. Avoid storing it in areas prone to moisture or electromagnetic interference.
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 | K173612 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Hualun Medical Systems Co., Ltd
- FDA Applicant
- Ge Hualun Medical Systems Co. , Ltd.
Sources (3)
- FDA 510(k) K173612 24 fields · synced Sep 18, 2026
- FDA UDI 4ca97eb0-27e6-42a7-a9e3-bcf36ce81c62 34 fields · synced May 30, 2026
- EUDAMED 608af7d7-cba5-461b-a9f9-b17de4a68cf1 61 fields · synced Jul 25, 2026