Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory
by Barzell-Whitmore Maroon Bells, Inc.
510(k) K972672
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972672 | Date29 Jul 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ITX
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1570
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Brachystepper Stepping Unit, Brachystepper Needle Guide Template, and Brachystand Support are a set of accessories designed for use in brachytherapy procedures. These components assist in precise needle placement and positioning during radiation therapy, ensuring accurate delivery of radioactive sources to targeted tissue areas. The stepping unit facilitates incremental adjustments, while the needle guide template and support accessory provide stability and alignment during treatment planning and execution.
This device is intended for reusable, non-sterile use in clinical settings. It is classified under product code ITX and has received FDA 510(k) clearance through the Radiology Advisory Committee. The components are not intended for MRI environments and require proper storage to maintain functionality. The system is supplied as a modular assembly, with each accessory serving a distinct role in enhancing procedural accuracy and safety.
Other devices from Barzell-Whitmore Maroon Bells, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Brachystepper system used for in brachytherapy procedures?
The Brachystepper system consists of a stepping unit, needle guide template, and support accessory, designed to assist in precise needle placement during brachytherapy. The stepping unit allows for incremental adjustments, while the needle guide template and support ensure stability and alignment, helping to deliver radioactive sources accurately to targeted tissue areas during radiation therapy.
Are the Brachystepper accessories intended for single-use or reusable applications?
The Brachystepper accessories are explicitly designed for reusable, non-sterile use in clinical settings. This classification allows for repeated use in multiple procedures, provided proper cleaning and maintenance protocols are followed to preserve functionality and ensure safety.
Can these accessories be used in MRI environments?
No, the Brachystepper accessories are not intended for use in MRI environments. This restriction is due to potential interference with magnetic resonance imaging systems, which could compromise both the device’s performance and patient safety.
How are the Brachystepper components supplied, and what roles do they play?
The system is supplied as a modular assembly, with each component serving a distinct purpose: the stepping unit facilitates incremental needle adjustments, the needle guide template ensures precise alignment, and the support accessory provides stability during treatment planning and execution. This modular design enhances procedural accuracy and safety.
What storage requirements are necessary to maintain the functionality of the Brachystepper accessories?
Proper storage is essential to maintain the functionality of the Brachystepper accessories. While the device is reusable and non-sterile, it should be stored in a clean, dry environment away from sources of contamination, moisture, or physical damage. Following manufacturer guidelines for maintenance will help ensure long-term reliability and performance.