Stereotactic Biopsy Attachment
by Siemens Medical Solutions USA, Inc.
510(k) K884107
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884107 | Date5 May 1989 | 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- Withdrawn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
- IZH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1710
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Stereotactic Biopsy Attachment is a device designed for use with mammographic X-ray systems to facilitate precise stereotactic breast biopsy procedures. It enables radiologists to obtain tissue samples from targeted areas within the breast under imaging guidance, improving accuracy and reducing the need for repeat procedures. This attachment integrates with existing mammography systems to enhance diagnostic workflows in radiology settings.
The device is supplied as a reusable component for integration with Class 2 mammographic X-ray systems, as defined by FDA product code IZH. It is intended for use in radiology departments and requires proper sterilization and maintenance per manufacturer guidelines. The attachment was cleared through the FDA’s Traditional 510(k) pathway in 1989 under registration number K884107, adhering to regulatory standards for radiology devices. No additional regulatory markings or MRI safety classifications are specified in the available data.
Other devices from Siemens Medical Solutions USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Stereotactic Biopsy Attachment used for?
The Stereotactic Biopsy Attachment is designed to work with mammographic X-ray systems to enable radiologists to perform precise stereotactic breast biopsies. It allows targeted tissue sampling under real-time imaging guidance, reducing the likelihood of inaccurate results or the need for repeat procedures. This improves diagnostic confidence and efficiency in radiology departments.
How is the Stereotactic Biopsy Attachment supplied and intended for use?
This attachment is supplied as a reusable component specifically intended for integration with Class 2 mammographic X-ray systems, as categorized under FDA product code IZH. It is meant for use exclusively in radiology settings where breast biopsies are performed. Proper sterilization and maintenance are required to ensure safe and effective operation, following manufacturer guidelines.
Is the device single-use or reusable?
The Stereotactic Biopsy Attachment is designed as a reusable component. Its durability and repeated use are supported by its integration with existing mammography systems, provided it undergoes proper sterilization and maintenance between procedures. This design aligns with the FDA’s classification of it as a reusable device for radiology applications.
What regulatory pathway was followed for this device?
The Stereotactic Biopsy Attachment was cleared through the FDA’s Traditional 510(k) pathway in 1989 under registration number K884107. This pathway was used to demonstrate that the device is substantially equivalent to a legally marketed predicate device, adhering to regulatory standards for radiology equipment. The clearance confirms its compliance with FDA requirements for safety and effectiveness.
What types of mammographic systems is this attachment compatible with?
The attachment is designed for integration with Class 2 mammographic X-ray systems, as defined by FDA product code IZH. While the exact models are not specified, its compatibility is intended for systems within this category, ensuring it functions seamlessly with existing radiology infrastructure. Always verify compatibility with your specific system before use.