# K971700: Biopsy Accessory for Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: Jul 9, 1997 after 62 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831317 (1983). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912088: Biopsy Accessories for Ultrasound Probes, Biosound, Inc. (1991) Summary page 1.
- K831317: Biopsy Attachment, Diasonics, Inc. (1983) Summary page 1.

## Indications for use
The ultrasound system provides imaging information, used to guide the biopsy needle through the accessory to the anatomical site where the sample of physiological material is recovered for further analysis.

Source page: https://510kreport.com/device/K971700
Methodology: https://510kreport.com/methodology