DuraDiagnost X-Ray System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DuraDiagnost EUDAMEDFDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- DuraDiagnost EUDAMEDStationary x-ray system FDA UDI
- Model / Reference
- 712203 EUDAMEDDuraDiagnost FDA UDI
- Description
- Stationary x-ray system FDA UDI
Identifiers
- Catalog Number
- 712203 FDA UDI
- Primary DI / UDI-DI
- 00884838095205 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM287TA EUDAMED
- Direct Marketing DI
- 00884838095205 EUDAMED
- FDA Product Code
- KPR FDA 510(k)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
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- Not 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
Yes
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 DuraDiagnost is a stationary X-ray imaging system designed for radiography. It incorporates key components such as an integrated tube column, a patient table with a floating tabletop, and a high-voltage generator to produce high-quality radiographic images. This system supports dual-focus rotation anode technology for enhanced imaging performance across various clinical applications.
The DuraDiagnost is intended for use in radiology departments and clinical settings requiring stationary X-ray imaging. It is supplied as a reusable, non-sterile device with multiple model and reference codes (e.g., 3003768277, 3009715136). The system complies with FDA 510(k) clearance and MDR authorizations, adhering to regulatory standards for Class II medical devices under product code KPR. Storage and handling follow manufacturer guidelines to ensure optimal performance and safety.
Frequently asked questions
What clinical settings is the DuraDiagnost designed for and how does its dual-focus rotation anode technology benefit users?
The DuraDiagnost is specifically designed for radiology departments and clinical settings requiring stationary X-ray imaging. Its dual-focus rotation anode technology enhances imaging performance by providing flexibility in selecting focal spots, which improves image quality for a wider range of clinical applications, such as general radiography, trauma imaging, and other diagnostic procedures.
Is the DuraDiagnost a single-use or reusable device, and what does that mean for maintenance and cost?
The DuraDiagnost is a reusable, non-sterile device. This means it is built for long-term use in clinical settings, requiring regular maintenance and calibration to ensure consistent performance and safety. While the upfront cost may be higher, the reusable nature can reduce long-term expenses compared to single-use alternatives.
What are the key components of the DuraDiagnost, and how do they contribute to its functionality?
The DuraDiagnost includes an integrated tube column, a patient table with a floating tabletop, and a high-voltage generator. The integrated tube column ensures precise X-ray production, the floating tabletop allows for smooth patient positioning and comfort, and the high-voltage generator delivers the necessary power for high-quality radiographic images, all contributing to its reliability and versatility in radiology.
How should the DuraDiagnost be stored, and what guidelines should be followed to maintain its performance?
The DuraDiagnost should be stored and handled according to the manufacturer’s guidelines to ensure optimal performance and safety. While specific storage conditions aren’t detailed here, typical recommendations for stationary X-ray systems include protecting the device from physical damage, extreme temperatures, and humidity, as well as keeping it in a clean, dry environment. Regular maintenance checks should also be conducted as per the manufacturer’s instructions.
What regulatory pathways has the DuraDiagnost followed, and what does this mean for its compliance and use in clinical settings?
The DuraDiagnost has obtained FDA 510(k) clearance and MDR (Medical Device Regulation) authorizations, indicating compliance with regulatory standards for Class II medical devices under product code KPR. This means the device has undergone evaluation to ensure its safety, effectiveness, and performance, allowing it to be legally marketed and used in clinical settings where stationary X-ray imaging is required, such as radiology departments.
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 Philips Healthcare (Suzhou) Co., Ltd. July 9, 2020 Mary Zhu Senior ..., Philips - DuraDiagnost Digital radiography systems - Philips, DuraDiagnost (K201640) - FDA 510 (k)
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 | K141381 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
Sources (3)
- FDA 510(k) K141381 24 fields · synced Sep 20, 2026
- FDA UDI 0597d8d6-7af7-484e-875d-034c4e64d481 38 fields · synced May 30, 2026
- EUDAMED 80d2fbc6-7ad4-4eb0-9662-00005cb11be0 61 fields · synced Jul 28, 2026