MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS— 510(k) K080930

Name: FDA 510(k) clearance K080930
Creator: U.S. Food and Drug Administration
Published: 2008-08-07

Substantially Equivalent

U-System, Inc.

FDA 510(k) clearance K080930 for MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS, Substantially Equivalent on 2008-08-07. Applicant: U-System, Inc.. Device class: 2.

Clearance details

Applicant: U-System, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2008-04-02
Decision date: 2008-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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 →

Recalls naming K080930

K-number listed on FDA's recall record

Z-1587-2013 — Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.Class II·Terminated·U-systems Inc·20130516

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080930.

Data sourced from openFDA. This site is unofficial and independent of the FDA.