Cleared Traditional

K161354 - MELODY

K161354 is an FDA 510(k) clearance for MELODY, manufactured by Adecho Tech. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K161354 · Adecho Tech · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
392d
Days
Class 2
Risk

K161354 is an FDA 510(k) clearance for the MELODY, Remote Control System for Ultrasound Probe. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Adecho Tech (Naveil, FR). The FDA issued a Cleared decision on June 12, 2017 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Adecho Tech devices

FDA 510(k) Submission Details - K161354

510(k) Number K161354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2016
Decision Date June 12, 2017
Days to Decision 392 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
285d slower than avg
Panel avg: 107d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

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 488
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K161354.
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
K172455 · Volcano Corporation · Oct 2017
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
K171824 · Edan Instruments, Inc. · Jul 2017
Acuson SC2000 Diagnostic Ultrasound System
K171766 · Siemens Medi Cal Solutions, Inc. · Jul 2017
CORE M2 Vascular System
K170385 · Volcano Corporation · Apr 2017
Acclarix AX8 Diagnostic Ultrasound System
K161300 · Edan Instruments, Inc. · May 2016
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
K153369 · Volcano Corporation · Dec 2015