Identifiers
- 510(k) Number
- K942792 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 Bucky Stand BR-10M is a stationary X-ray system component designed as a radiographic grid support stand. It functions as a mobile or fixed bucky device, providing precise alignment and stability for X-ray imaging tables to reduce scatter radiation and improve image clarity during radiography procedures. This device is integral to radiology workflows, ensuring consistent positioning of the image receptor during exposures.
The Bucky Stand BR-10M is supplied as a reusable medical device intended for use in radiology settings. It is classified under FDA product code KPR as a Class II device, subject to special controls. The stand is not described as sterile or single-use in the regulatory data, and no MRI safety information is provided. The device was cleared under FDA 510(k) with K-number K942792 in 1994, with no additional regulatory status implied beyond the stated clearance. Storage and maintenance instructions are not specified in the available data.
Frequently asked questions
What is the Bucky Stand BR-10M used for in radiology procedures?
The Bucky Stand BR-10M is designed as a radiographic grid support stand to stabilize and align X-ray imaging tables. It functions as either a mobile or fixed bucky device, ensuring the image receptor remains consistently positioned during exposures. This precise alignment minimizes scatter radiation, which improves image clarity and quality in radiography, making it essential for accurate diagnostic imaging.
Is the Bucky Stand BR-10M intended for single-use or reusable applications?
The Bucky Stand BR-10M is explicitly described as a reusable medical device. It is not classified as single-use, meaning it is intended for repeated use in radiology settings after proper cleaning and maintenance. Reusability aligns with its design as a durable component of stationary X-ray systems.
Does the Bucky Stand BR-10M come sterile, and if not, what are the implications?
The Bucky Stand BR-10M is not described as a sterile device in the available regulatory data. Since it is reusable, sterility is not a requirement for its function. However, proper cleaning and maintenance protocols must be followed to ensure hygiene and prevent contamination between uses in clinical settings.
What regulatory pathway was followed for the Bucky Stand BR-10M’s clearance?
The Bucky Stand BR-10M was cleared through the FDA’s 510(k) pathway under the product code KPR, classified as a Class II device. It was determined to be substantially equivalent to a predicate device by the Radiology Advisory Committee (RA) and received clearance with K-number K942792 on July 29, 1994. This classification means it is subject to special controls relevant to radiographic grid support stands.
Are there specific storage or maintenance instructions provided for the Bucky Stand BR-10M?
The available regulatory data does not specify detailed storage or maintenance instructions for the Bucky Stand BR-10M. However, as a reusable medical device, it is recommended to follow general guidelines for cleaning, lubrication (if applicable), and environmental protection to ensure optimal performance and longevity. Consult the manufacturer’s operational manual for specific care recommendations.
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: K942792 FDA 510(k) - BUCKY STAND BR-10M | Shimadzu Corp., Shimadzu Bucky Stand BR-10M - allmed.wiki, BUCKY STAND BR-10M (K942792) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K942792 | Class II | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corp.
Sources (1)
- FDA 510(k) K942792 24 fields · synced Oct 1, 2026