Ultrasound System SONIMAGE HS1— 510(k) K151060

Name: FDA 510(k) clearance K151060
Creator: U.S. Food and Drug Administration
Published: 2015-06-05

Substantially Equivalent

Konica Minolta, Inc.

FDA 510(k) clearance K151060 for Ultrasound System SONIMAGE HS1, Substantially Equivalent on 2015-06-05. Applicant: Konica Minolta, Inc.. Device class: 2.

Clearance details

Applicant: Konica Minolta, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2015-04-20
Decision date: 2015-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hino-Shi, JP

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 K151060

K-number listed on FDA's recall record

Z-1215-2018 — Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588Class II·Terminated·Konica Minolta Medical Imaging USA, Inc.·20171204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151060.

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