Cleared Traditional

K180084 - Ultrasound System SONIMAGE MX1 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180084 · Konica Minolta, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
28d
Days
Class 2
Risk

K180084 is an FDA 510(k) clearance for the Ultrasound System SONIMAGE MX1. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Konica Minolta, Inc. (Hino-Shi, JP). The FDA issued a Cleared decision on February 8, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Konica Minolta, Inc. devices

Submission Details

510(k) Number K180084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2018
Decision Date February 08, 2018
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 891
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K180084.
EdgeFlow UW20
K252237 · Edgecare, Inc. · Apr 2026
Accuro XV
K254021 · Rivanna Medical, Inc. · Apr 2026
QT Scanner 2000 Model A
K253898 · QT Imaging Holdings, Inc. · Mar 2026
IntraSight Plus
K253714 · Philips Image Guided Therapy Corporation · Feb 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · Eieling Technology (Shenzhen) Limited · Feb 2026
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · Astrasono Technology Co., Ltd. · Sep 2025