Xgeo Gr40cw
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- GR40CW EUDAMEDNA FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging conversion system FDA UDI
- Device Name
- Retrofit kit for digital radiography EUDAMEDThe GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. FDA UDI
- Model / Reference
- GR40CW EUDAMEDFDA UDIGR40CW, GR40CWD EUDAMED
- Description
- The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806088773797 EUDAMEDFDA UDI
- Basic UDI-DI
- 8806090DGRGR001YN EUDAMED
- 510(k) Number
- K140235 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)FDA UDI
- EMDN Code
- Z11031180 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Diagnostic x-ray digital imaging conversion system FDA UDI
Classification
- Device Class
- Class IIa 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
- Poland 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
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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
No
The XGEO GR40CW is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed as a retrofit solution for converting computed radiography (CR) systems to digital radiography (DR). It functions as a high-resolution digital detector that captures and processes X-ray images for diagnostic imaging purposes, replacing traditional film-based or phosphor plate systems.
This device is supplied as a reusable, non-sterile component intended for integration into existing radiography systems. It operates within standard radiology environments and is compatible with MRI-safe settings, though specific magnetic field interactions should be verified per facility protocols. The GR40CW is authorized under FDA 510(k) clearance and MDR, with regulatory classification as a Class II medical device (FDA: 892.1680). Multiple model variants are listed under OpenFDA, reflecting its broad compatibility with various radiography applications.
Frequently asked questions
What is the primary purpose of the XGEO GR40CW in a radiology setting?
The XGEO GR40CW is designed as a retrofit solution to upgrade existing computed radiography (CR) systems to digital radiography (DR). It replaces traditional film-based or phosphor plate systems by functioning as a high-resolution digital detector that captures and processes X-ray images for diagnostic imaging, improving efficiency and image quality in standard radiology environments.
Is the XGEO GR40CW intended for single-use or reusable applications, and what does that mean for maintenance?
The XGEO GR40CW is explicitly supplied as a reusable component, meaning it is not disposable. This design allows facilities to integrate it into existing systems without frequent replacements, though proper cleaning, calibration, and maintenance protocols must be followed to ensure consistent performance and longevity. Reusability also aligns with sustainability goals for radiology departments.
How does the XGEO GR40CW interact with MRI environments, and what precautions should be taken?
The device is noted as compatible with MRI-safe settings, but it explicitly states that specific magnetic field interactions should be verified per facility protocols. This means while it may not interfere with MRI operations in general, each radiology department must confirm compatibility with their particular MRI equipment and magnetic field strengths to avoid potential risks or image artifacts.
What regulatory pathways has the XGEO GR40CW followed, and what does that imply for purchasing or implementation?
The XGEO GR40CW has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, classifying it as a Class II medical device under FDA category 892.1680. This implies it has met stringent regulatory standards for safety and effectiveness, but purchasers should verify compliance with local healthcare regulations (e.g., FDA, EU MDR) and ensure their facility’s IT infrastructure can integrate the device as a retrofit solution for CR systems.
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: XGEO GR40CW (K140235) — FDA 510(k) | Innolitics, GR40CW Radiography Retrofit | Samsung Healthcare, GR40CW Digital Radiography (X-ray) | Samsung Healthcare Global
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140235 | Class II | Active |
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Manufacturer
- Manufacturer
- Samsung Electronics Co., Ltd.
Sources (3)
- FDA 510(k) K140235 24 fields · synced Sep 18, 2026
- FDA UDI 5e1cce2e-3e41-47fd-bf07-01ceadc0faa6 33 fields · synced May 29, 2026
- EUDAMED 4275c634-c266-4f33-b2df-494dbc49afc1 61 fields · synced Jul 26, 2026