Cleared Traditional

K173034 - FibroScan Family of Products (Models: 5...

K173034 is an FDA 510(k) clearance for FibroScan Family of Products (Models: 5..., manufactured by Echosens. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K173034 · Echosens · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
47d
Days
Class 2
Risk

K173034 is an FDA 510(k) clearance for the FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Echosens (Paris, FR). The FDA issued a Cleared decision on November 14, 2017 after a review of 47 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 Echosens devices

FDA 510(k) Submission Details - K173034

510(k) Number K173034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date November 14, 2017
Days to Decision 47 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
60d faster than avg
Panel avg: 107d · This submission: 47d
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 454
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K173034.
Wireless Probe Type Ultrasound Scanner (Model:UProbe-C
K172750 · Guangzhou Sonostar Technologies Co., Ltd. · Feb 2018
Ultrasound System SONIMAGE MX1
K180084 · Konica Minolta, Inc. · Feb 2018
Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
K171528 · Avantsonic Technology Co., Ltd. · Jan 2018
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