SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM— 510(k) K072541

Clearance details

Applicant

Senorx, Inc.

Product code

Code ITX

Device class

Class 2

Regulation

21 CFR 892.1570

Advisory panel

Radiology

Date received

2007-09-10

Decision date

2007-09-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Aliso Viejo, CA, US

• K261170 — BA-004CC2026-08-12
• K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
• K260161 — SmartGuide Disposable Guides and Grids2026-07-30
• K262474 — ND Needle Guidance System2026-07-27
• K261014 — Accuro® 3S Needle Guide Kit2026-07-24

• K233220 — EnCor EnspireBreast Biopsy System (E4115, E4230) +4 more2023-10-27
• K210654 — EnCor Breast Biopsy Probe with Rinse Tube2021-03-31
• K161805 — EnCor MRI Introducer Set, EnCor Probe Introducer2016-07-19
• K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER2013-06-27
• K093512 — ENCOR BREAST BIOPSY SYSTEM2009-11-20

Death

6

Injury

137

Malfunction

2,036

Total

2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →