Cleared Traditional

K161919 - UltraScan 650

K161919 is an FDA 510(k) clearance for UltraScan 650, manufactured by Cyberlogic, Inc.. The device is a Class 2 Radiology device with product code MUA cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K161919 · Cyberlogic, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
266d
Days
Class 2
Risk

K161919 is an FDA 510(k) clearance for the UltraScan 650. Classified as Bone Sonometer (product code MUA), Class II - Special Controls.

Submitted by Cyberlogic, Inc. (New York, US). The FDA issued a Cleared decision on April 5, 2017 after a review of 266 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.

FDA 510(k) Submission Details - K161919

510(k) Number K161919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2016
Decision Date April 05, 2017
Days to Decision 266 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
159d slower than avg
Panel avg: 107d · This submission: 266d
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

Promedic, Inc.
Paul Dryden

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.

Regulatory Peers - MUA Bone Sonometer

All 8
Devices cleared under the same product code (MUA) and FDA review panel - the closest regulatory comparables to K161919.
Bindex BI-2
K211350 · Bone Index Finland , Ltd. · Apr 2022
EchoS Family
K202514 · Echolight S.P.A · Feb 2021
EchoS
K180516 · Echolight S.P.A · Oct 2018
Bindex BI-2
K161971 · Bone Index Finland , Ltd. · Jan 2017
Bindex BI-100
K152020 · Bone Index Finland , Ltd. · May 2016
ACHILLES
K123238 · Ge Medical Systems China Co., Ltd. · Feb 2013
K161919 · UltraScan 650
Download PDF FDA Summary Cyberlogic, Inc.