Promo Mobile X-Ray System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PROMO EUDAMEDDRGEM FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Mobile X-ray System EUDAMEDPower Specification : 200-240 V~ / 125kV FDA UDI
- Model / Reference
- PROMO EUDAMEDFDA UDI
- Description
- Power Specification : 200-240 V~ / 125kV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011150112 EUDAMEDFDA UDI08800011151003 EUDAMED
- Basic UDI-DI
- 88000111DMP5000ZP EUDAMED
- 510(k) Number
- 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
- Türkiye EUDAMEDPoland 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
Yes
The Promo Mobile X-Ray System is a portable radiographic imaging device designed for mobile radiography applications. It generates high-quality X-ray images for diagnostic purposes, supporting flexible positioning and stable mobility to enhance workflow efficiency in various clinical settings.
This system is intended for single-use or reusable applications, depending on the configuration, and is regulated under FDA 510(k) clearance and MDR compliance. It operates within Class II medical device classification and is intended for use in radiology departments, emergency settings, and other mobile imaging scenarios. The device is supplied with multiple FEI numbers and registration identifiers, ensuring traceability and adherence to regulatory standards.
Frequently asked questions
What clinical settings is the Promo Mobile X-Ray System designed to improve workflow efficiency in, and how does its portability benefit these environments?
The Promo Mobile X-Ray System is specifically designed for flexible positioning and stable mobility, making it ideal for radiology departments, emergency settings, and other mobile imaging scenarios. Its portability allows for easy transport to patient bedsides, operating rooms, or remote locations, reducing the need for patient transfers and streamlining diagnostic imaging workflows in dynamic or space-constrained environments.
How is the Promo Mobile X-Ray System configured for use—is it intended for single-use or reusable applications, and what does this mean for maintenance?
The Promo Mobile X-Ray System can be configured for either single-use or reusable applications, depending on the specific setup. If reusable, it requires proper cleaning, disinfection, and maintenance protocols to ensure safety and functionality between uses, while single-use configurations eliminate these steps but may involve disposal considerations.
What regulatory pathways does the Promo Mobile X-Ray System follow, and how does this affect its traceability and compliance?
The Promo Mobile X-Ray System is regulated under both FDA 510(k) clearance and MDR compliance, classifying it as a Class II medical device. It is supplied with multiple FEI (Facility Establishment Identifier) numbers and registration identifiers, ensuring traceability and adherence to regulatory standards for tracking and accountability in clinical and administrative settings.
Are there different sizes or models of the Promo Mobile X-Ray System, and if so, how might this affect its suitability for various clinical needs?
While the provided data does not specify distinct size or model variations, the Promo Mobile X-Ray System is designed for mobile radiography applications, implying flexibility in positioning and adaptability to different clinical environments. If multiple FEI numbers and registration identifiers are associated with different configurations, these may correspond to variations in functionality or portability tailored to specific workflows or patient needs.
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: Promo - Drgem, DRGEM Corporation FDA 510(k) Radiology Products - Latest 2026, PDF OSCT2406-001_PROMO_4P_R26 - ti-ba.com
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 | K251443 | Class II | Active |
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Manufacturer
- Manufacturer
- DRGEM Corporation
Sources (4)
- FDA 510(k) K251443 24 fields · synced Sep 18, 2026
- FDA UDI 47f21e8f-9817-4e8d-9c16-6cfa9ca12993 34 fields · synced May 30, 2026
- EUDAMED a51c770d-ef7c-45ec-a4ed-44ea81a0cf62 61 fields · synced Jul 12, 2026
- EUDAMED 5b615245-8308-456e-816f-7246055d6147 61 fields · synced Jul 21, 2026