Cleared Traditional

K150949 - FibroScan

K150949 is an FDA 510(k) clearance for FibroScan, manufactured by Echosens. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K150949 · Echosens · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
56d
Days
Class 2
Risk

K150949 is an FDA 510(k) clearance for the FibroScan. 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 June 3, 2015 after a review of 56 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 - K150949

510(k) Number K150949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2015
Decision Date June 03, 2015
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 K150949.
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
K152554 · C.R. Bard, Inc. · Dec 2015
iLab Ultrasound Imaging System
K152316 · Boston Scientific · Sep 2015
Ultrasound System SONIMAGE HS1
K151060 · Konica Minolta, Inc. · Jun 2015
Touch Ultrasound
K150342 · Carestream Health, Inc. · May 2015
Acclarix Diagnostic Ultrasound System
K150999 · Edan Instruments, Inc. · May 2015
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
K150529 · C.R. Bard, Inc. · Mar 2015