Diamond-5a/6a/8a
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DIAMOND-5A EUDAMEDDIAMOND-8A EUDAMEDDIAMOND-6A EUDAMEDDRGEM FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Digital diagnostic X-ray System EUDAMED*Line power rating: 480V3~ *MAX Tube voltage: 150kV FDA UDI*Line power rating: 480V3~ *MAX Tube voltage: 150kV FDA UDI*Line power rating: 400V3~ *MAX Tube voltage: 150kV FDA UDI*Line power rating: 400V3~ *MAX Tube voltage: 150kV FDA UDI220-230V~/150kV FDA UDI
- Model / Reference
- DIAMOND-6A EUDAMEDFDA UDIDIAMOND-8A EUDAMEDFDA UDIDIAMOND-5A EUDAMEDFDA UDIDIAMOND-5A, DIAMOND-6A, DIAMOND-8A EUDAMED
- Description
- *Line power rating: 480V3~ *MAX Tube voltage: 150kV FDA UDI*Line power rating: 480V3~ *MAX Tube voltage: 150kV FDA UDI*Line power rating: 400V3~ *MAX Tube voltage: 150kV FDA UDI*Line power rating: 400V3~ *MAX Tube voltage: 150kV FDA UDI220-230V~/150kV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011140168 EUDAMEDFDA UDI08800011140175 EUDAMEDFDA UDI08800011140151 EUDAMEDFDA UDI08800011140014 EUDAMEDFDA UDI08800011140021 EUDAMEDFDA UDI08800011140007 EUDAMEDFDA UDI08800011140885 EUDAMEDFDA UDI08800011140892 EUDAMED
- Basic UDI-DI
- 88000111DSDIA4000GM EUDAMED
- 510(k) Number
- 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
- 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 Diamond 5A/6A/8A is a stationary X-ray imaging system designed for radiologic procedures. It provides high-resolution imaging for diagnostic evaluations, supporting a range of medical specialties within radiology. The device integrates advanced imaging technology to capture detailed radiographic images of internal structures, aiding in the assessment of bone, soft tissue, and vascular conditions.
This system is intended for use in clinical radiology settings and is supplied as a reusable medical device. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance and EU MDR authorisation. The device is not single-use and requires proper maintenance, calibration, and storage to ensure imaging accuracy and safety. Compliance with regulatory standards ensures its suitability for diagnostic imaging applications in accredited healthcare facilities.
Frequently asked questions
What types of medical specialties can benefit from using the Diamond 5A/6A/8A X-ray imaging system in their diagnostic evaluations?
The Diamond 5A/6A/8A is designed to support a broad range of medical specialties within radiology, including assessments of bone structures, soft tissues, and vascular conditions. Its high-resolution imaging capabilities make it particularly useful for general radiology, orthopedics, cardiology, and vascular diagnostics, where detailed visualization of internal anatomy is critical.
Is the Diamond 5A/6A/8A system reusable, and what maintenance does it require to ensure proper functionality?
Yes, the Diamond 5A/6A/8A is a reusable medical device, not intended for single-use. To maintain imaging accuracy and safety, it requires regular maintenance, calibration, and proper storage as outlined in the manufacturer’s guidelines. Compliance with these procedures is essential for ensuring reliable performance in clinical settings.
How is the Diamond 5A/6A/8A system authorized for use in the U.S. and Europe, and what does that mean for healthcare providers?
The system holds FDA 510(k) clearance and is classified as Class II, meaning it has been deemed substantially equivalent to a predicate device and meets U.S. regulatory standards for safety and effectiveness. In Europe, it carries EU MDR authorization, ensuring compliance with stringent medical device regulations. This dual authorization allows healthcare providers to confidently integrate the system into accredited facilities for diagnostic imaging.
What should clinicians or facility managers consider when storing the Diamond 5A/6A/8A to preserve its performance?
Since the Diamond 5A/6A/8A is a reusable device, proper storage is critical to prevent damage or degradation. The manufacturer’s instructions should specify environmental conditions (e.g., temperature, humidity) and protective measures to avoid dust, moisture, or physical stress. Regular inspections and adherence to maintenance schedules will also help sustain imaging quality and longevity.
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.
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 | K192453 | Class II | Active |
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Manufacturer
- Manufacturer
- DRGEM Corporation
Sources (16)
- FDA 510(k) K192453 24 fields · synced Sep 18, 2026
- FDA UDI 7a21a6ed-4aec-4874-bd9b-25c44efaccea 33 fields · synced May 30, 2026
- FDA UDI c3be53ac-f3ad-481a-b4f7-fe6262f1b170 33 fields · synced May 30, 2026
- FDA UDI 65e3416f-c36a-460a-bfd1-6cca3190cdc1 33 fields · synced May 30, 2026
- FDA UDI 3d43d3c1-4cd3-450c-bebe-475ad96552a5 33 fields · synced May 30, 2026
- FDA UDI a23f0f33-0007-45b6-a591-a43f7fdbda6e 33 fields · synced May 30, 2026
- FDA UDI 4e07aa7f-911e-4770-b0c7-4321aae3aa03 33 fields · synced May 30, 2026
- FDA UDI 7d411d18-427f-4d9a-87a3-6b019140cf4c 34 fields · synced May 30, 2026
- EUDAMED 7680e5d0-a196-46da-99d3-da54953b666e 61 fields · synced Jul 8, 2026
- EUDAMED 054b5ea5-8fa3-436c-b3a0-410233737230 61 fields · synced Jul 8, 2026
- EUDAMED 3fbf0ad8-7c80-4f9c-905d-e51a5a657b3b 61 fields · synced Jul 9, 2026
- EUDAMED d8cf9f5b-b698-4b20-9eec-f42bcb341034 61 fields · synced Jul 11, 2026
- EUDAMED cee258f7-3eb8-4970-8821-1a5405718b06 61 fields · synced Jul 11, 2026
- EUDAMED c811b5ed-24e0-4437-b786-7b067f45fc7b 61 fields · synced Jul 16, 2026
- EUDAMED 2cff8dd7-5e06-4de8-95c3-cd3889e6a044 61 fields · synced Jul 17, 2026
- EUDAMED 710ea5b5-329a-4e8d-afa6-393020142c51 61 fields · synced Aug 1, 2026