Identity
- Trade Name
- GM85 EUDAMEDNA FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Digital Diagnostic Mobile X-ray System EUDAMEDThe GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. FDA UDI
- Model / Reference
- GM85 EUDAMEDFDA UDI
- Description
- The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806088582412 EUDAMEDFDA UDI
- Basic UDI-DI
- 8806090DGRGM001XK EUDAMED
- 510(k) Number
- K220175 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)FDA UDIMQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Mobile 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 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)FDA UDI892.1680 FDA UDI
- Market of Registration
- Finland 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 GM85 is a Mobile X-Ray System (OpenFDA classification: IZL) designed for portable radiographic imaging. It generates X-ray images by transmitting ionizing radiation through a patient’s body, capturing the resulting signals via detectors and converting them into digital data for diagnostic evaluation. The system is configured for versatile radiographic applications, including general radiography and specialized imaging in mobile settings.
The GM85 is supplied as a reusable, non-sterile device intended for use in clinical radiology departments, emergency settings, or mobile imaging units. It features optional configurations, such as a collapsible column type with manual collimation, multiple detector options, and wired/wireless exposure switches. The system operates under FDA 510(k) clearance (K220175, K222353) and EU MDR compliance, with no MRI safety restrictions. Storage and handling follow standard radiographic equipment protocols.
Frequently asked questions
What types of imaging tasks is the GM85 designed to support in mobile settings?
The GM85 is specifically designed for portable radiographic imaging, making it suitable for general radiography and specialized mobile applications. Its versatility allows it to be used in clinical radiology departments, emergency settings, or mobile imaging units, where flexibility and portability are essential for capturing X-ray images on the go.
Is the GM85 system reusable or single-use, and what does that mean for maintenance?
The GM85 is a reusable device, meaning it is not intended for single-use disposal. This design implies that it requires regular cleaning, maintenance, and calibration to ensure consistent performance and safety. The manufacturer recommends following standard radiographic equipment protocols for storage and handling to maintain its functionality.
What options are available for configuring the GM85’s collimation and exposure controls?
The GM85 offers optional configurations, including a collapsible column type with manual collimation to precisely control the X-ray beam. Additionally, it supports multiple detector options and provides flexibility in exposure switches, available in both wired and wireless variants, to accommodate different clinical workflows and preferences.
How does the GM85’s regulatory compliance affect its use in different regions?
The GM85 holds both FDA 510(k) clearance (with specific K-numbers) and EU MDR compliance, ensuring it meets regulatory standards in the United States and European Union. This dual compliance allows healthcare providers in these regions to use the device with confidence, adhering to local safety and performance requirements. However, regional guidelines for storage, maintenance, and usage should still be followed.
Are there any size or model variations for the GM85, and how might they impact clinical use?
The GM85 is associated with multiple registration numbers and product codes, indicating it may come in various configurations or models tailored for different clinical needs. While the exact specifications of each model aren’t detailed here, these variations likely include differences in detector types, collimation options, or other technical features to optimize performance for general radiography, emergency use, or specialized mobile imaging scenarios.
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: PDF Samsung Electronics Co. Ltd. Jaesang Noh Senior Professional ..., PDF October 1, 2024 SAMSUNG ELECTRONICS Co., Ltd. 129, Samsung-ro ..., K222353 FDA 510(k) - GM85 | Samsung Electronics Co., Ltd.
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 | K220175 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Samsung Electronics Co., Ltd.
Sources (3)
- FDA 510(k) K220175 24 fields · synced Sep 18, 2026
- FDA UDI 75a102b0-35a6-41b5-9853-a1b4271f196b 33 fields · synced May 30, 2026
- EUDAMED 4afc4439-eeab-40a6-8334-feb5e847e3b5 61 fields · synced Jul 13, 2026