Cleared Traditional

K231659 - MS55 Plus Digital Color Doppler Ultrasound System (MS55) (FDA 510(k) Clearance)

Also includes:
P25 Expert Digital Color Doppler Ultrasound System (P25 Expert) P12 Plus Digital Color Doppler Ultrasound System (P12 Plus) P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus) P9 Plus Ultrasound Diagnostic System (P9 Plus) P3 Plus Ultrasound Diagnostic System (P3 Plus)

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

K231659 · Medisono · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
253d
Days
Class 2
Risk

K231659 is an FDA 510(k) clearance for the MS55 Plus Digital Color Doppler Ultrasound System (MS55). Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Medisono (Doral, US). The FDA issued a Cleared decision on February 15, 2024 after a review of 253 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K231659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2023
Decision Date February 15, 2024
Days to Decision 253 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 107d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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