Identifiers
- 510(k) Number
- K202156 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Diamond-5A/6A/8A is a stationary X-ray imaging system (product code KPR), combining a digital flat panel detector with an automatic motorized U-arm radiographic stand and mobile patient table. It is designed for radiography applications, providing high-resolution imaging without requiring ceiling-mounted tube suspensions, making it adaptable to smaller clinical spaces.
This device is supplied as a reusable, non-sterile system intended for use in radiology departments. It operates under FDA 510(k) clearance (K202156) as a Class II medical device under special controls, regulated under 21 CFR 892.1680. The system includes multiple detector configurations, as indicated by the model variants (5A, 6A, 8A), and is intended for stationary radiographic imaging applications.
Frequently asked questions
What types of imaging tasks is the Diamond-5A/6A/8A designed to perform, and why is it considered adaptable for smaller spaces?
The Diamond-5A/6A/8A is a stationary X-ray imaging system designed for radiography applications, providing high-resolution images. Its adaptability to smaller clinical spaces comes from its motorized U-arm radiographic stand and mobile patient table, which eliminate the need for ceiling-mounted tube suspensions. This makes it suitable for general radiographic imaging in radiology departments where space efficiency is important.
Is the Diamond-5A/6A/8A system reusable or single-use, and what does that mean for maintenance and cleaning?
The Diamond-5A/6A/8A is supplied as a reusable system, meaning it is not intended for single-use disposal. This implies that the device must be cleaned, disinfected, and maintained between uses according to established protocols to ensure patient safety and device longevity. Reusability also means it requires proper storage and handling to prevent damage or contamination.
What are the key differences between the Diamond-5A, 6A, and 8A models, and how do they relate to detector configurations?
The Diamond-5A, 6A, and 8A models differ primarily in their detector configurations, as indicated by the model variants. While the exact specifications of each detector size are not detailed here, the numerical suffixes (5A, 6A, 8A) likely correspond to variations in detector dimensions or resolution capabilities. These differences allow for flexibility in imaging applications, such as accommodating different patient sizes or anatomical regions, while maintaining compatibility with the system’s motorized U-arm and mobile table.
How should the Diamond-5A/6A/8A system be stored, and are there any special considerations for its non-sterile nature?
Since the Diamond-5A/6A/8A is a reusable, non-sterile system, it should be stored in a clean, dry environment protected from dust, moisture, and physical damage. The manufacturer’s guidelines (not provided here) should outline specific storage conditions, but generally, this includes keeping the system covered when not in use and ensuring the mobile table and U-arm are securely positioned to prevent accidental movement. Sterilization is not required, but routine cleaning and maintenance are essential to prevent contamination and ensure optimal performance.
What regulatory pathway was followed for the Diamond-5A/6A/8A, and what does this mean for its use in clinical settings?
The Diamond-5A/6A/8A was cleared through the FDA’s 510(k) pathway (K202156) as a Class II medical device under special controls, regulated under 21 CFR 892.1680. This means the device was deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness. Clinically, this clearance allows the system to be used in radiology departments for stationary radiographic imaging applications, provided it is used as intended and adheres to manufacturer instructions and regulatory guidelines.
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 DRGEM Corporation September 10, 2020 ℅ Mr. Carl Alletto Regulatory ..., K202156 - DIAMOND-5A/6A/8A | FDA 510(k) | DRGEM Corporation, DIAMOND-5A/6A/8A 510 (k) K192453 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202156 | Class II | Active |
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Manufacturer
- Manufacturer
- DRGEM Corporation
Sources (1)
- FDA 510(k) K202156 24 fields · synced Sep 19, 2026