# K072541: Senosonix Ultrasound Breast Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Senorx, Inc.
- Decided: Sep 25, 2007 after 15 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: 4 generations back to K935595 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023923: Senocor 360 Circumferential Vacuum Assisted Biopsy Device, 8 Gauge, Senorx, Inc. (2002) Summary page 1.
- K040842: Senorx Biopsy Device II, Senorx, Inc. (2004) Summary page 1.
- K061827: Sonix Ultrasound Scanner, Ultrasonix Medical Corporation (2006) Summary page 1.

## Indications for use
The SenoSonix Ultrasound Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. The ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.

Source page: https://510kreport.com/device/K072541
Methodology: https://510kreport.com/methodology