Cleared Traditional

K180516 - EchoS

K180516 is an FDA 510(k) clearance for EchoS, manufactured by Echolight S.P.A. The device is a Class 2 Radiology device with product code MUA cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K180516 · Echolight S.P.A · Radiology device
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Oct 2018
Decision
234d
Days
Class 2
Risk

K180516 is an FDA 510(k) clearance for the EchoS. Classified as Bone Sonometer (product code MUA), Class II - Special Controls.

Submitted by Echolight S.P.A (Lecce, IT). The FDA issued a Cleared decision on October 19, 2018 after a review of 234 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1180 - 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.

View all Echolight S.P.A devices

FDA 510(k) Submission Details - K180516

510(k) Number K180516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2018
Decision Date October 19, 2018
Days to Decision 234 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
127d slower than avg
Panel avg: 107d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUA Device Classification - Class 2, Special Controls

Product Code MUA Bone Sonometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1180
Definition A Bone Sonometer Is A Device That Transmits Ultrasound Energy Into The Human Body To Measure Acoustic Properties Of Bone That Indicate Overall Bone Health And Fracture Risk. The Primary Components Of The Device Are A Voltage Generator, A Transmitting Transducer, A Receiving Transducer, And Hardware And Software For Reception And Processing Of The Received Ultrasonic Signal. Reclassified From Class 3 Pma To Class 2 510(k) 892.1180 [docket No. Fda-2005-n-0346] Reclassification Of Bone Sonometers
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 Consultant

Isemed S.R.L.
Maurizio Pantaleoni

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.