Topaz Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- TOPAZ-32D EUDAMEDTOPAZ-40D EUDAMEDDRGEM FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Mobile X-ray System EUDAMED100~240V/125kV FDA UDI100~240V/150kV FDA UDI
- Model / Reference
- TOPAZ-32D EUDAMEDFDA UDITOPAZ-40D EUDAMEDFDA UDITOPAZ-32D, TOPAZ-40D EUDAMED
- Description
- 100~240V/125kV FDA UDI100~240V/150kV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011150006 EUDAMEDFDA UDI08800011150013 EUDAMEDFDA UDI08800011150037 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000111DM5000VU EUDAMED
- 510(k) Number
- K242015 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)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 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
Yes
The Topaz Mobile X-ray System (Models: TOPAZ-32D, TOPAZ-40D) is a mobile radiographic imaging device designed for portable X-ray imaging. It provides real-time radiographic visualization, enabling diagnostic imaging in diverse clinical settings such as emergency rooms, operating rooms, and patient rooms.
This system is intended for use in radiology departments and is supplied as a reusable medical device. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The system is not MRI-safe and requires proper storage and maintenance in accordance with manufacturer guidelines.
Frequently asked questions
What clinical environments is the TOPAZ Mobile X-ray System designed to operate in and why is portability important for these settings?
The TOPAZ Mobile X-ray System is specifically designed for portable radiographic imaging in diverse clinical settings such as emergency rooms, operating rooms, and patient rooms. Portability is critical in these environments because it allows for immediate imaging at the patient’s location, reducing the need for patient transfer and enabling faster diagnostic evaluations. This is particularly useful in acute care scenarios where time-sensitive decisions are required.
Is the TOPAZ Mobile X-ray System reusable, and if so, what maintenance or care instructions should be followed?
Yes, the TOPAZ Mobile X-ray System is supplied as a reusable medical device. Since it is reusable, proper storage and maintenance are essential to ensure its longevity and performance. The manufacturer provides specific guidelines for cleaning, calibration, and upkeep, which should be strictly followed to maintain imaging quality and safety. These instructions are typically detailed in the device’s user manual or operational guidelines.
Are there different models of the TOPAZ Mobile X-ray System, and if so, how do they differ?
Yes, the TOPAZ Mobile X-ray System comes in two models: the TOPAZ-32D and the TOPAZ-40D. While the exact technical differences between these models are not specified in the provided data, the numerical distinction (32D vs. 40D) likely refers to variations in imaging capabilities, such as detector size or resolution, which may influence their suitability for different clinical applications. For precise differences, refer to the manufacturer’s specifications or consult with DRGEM Corporation.
What regulatory pathways has the TOPAZ Mobile X-ray System undergone, and what does this mean for its use in clinical settings?
The TOPAZ Mobile X-ray System has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, indicating it has been evaluated for safety and effectiveness according to regulatory standards. This means the device has met the necessary requirements for marketing and use in the United States and the European Economic Area, respectively. Clinicians can rely on these approvals as evidence of the device’s compliance with regulatory expectations for portable radiographic imaging systems.
Is the TOPAZ Mobile X-ray System safe to use in proximity to MRI machines, and why is this important?
No, the TOPAZ Mobile X-ray System is explicitly stated as not MRI-safe. This is important because using non-MRI-safe devices near MRI machines can pose risks to both the device and the patient, such as interference with MRI imaging or potential damage to the X-ray system. Clinicians must ensure the device is not placed in or near an MRI environment to avoid complications or safety hazards.
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: Professional photo & video enhancement powered by AI | Topaz Labs
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 | K242015 | Class II | Active |
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Manufacturer
- Manufacturer
- DRGEM Corporation
Sources (7)
- FDA 510(k) K242015 24 fields · synced Sep 18, 2026
- FDA UDI c8c15923-4914-480c-a6d8-115873eb3d67 33 fields · synced May 30, 2026
- FDA UDI 0a70cfa8-c86c-4bfa-bdc8-0518854e6f9c 33 fields · synced May 30, 2026
- FDA UDI 2f5acce7-2a56-4622-a213-c61fab3d054a 33 fields · synced May 30, 2026
- EUDAMED fd6e8147-81e1-4184-96bd-99913f92198a 61 fields · synced Jul 28, 2026
- EUDAMED c809ba8b-97b8-4b89-b21b-f1a5f60406e0 61 fields · synced Jul 29, 2026
- EUDAMED 3b38ead0-a4ee-47c4-b244-755bf5a38604 61 fields · synced Jul 31, 2026