Cleared Traditional

K150239 - FibroScan

K150239 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 211-day FDA review.

K150239 · Echosens · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
211d
Days
Class 2
Risk

K150239 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 September 1, 2015 after a review of 211 days - an extended review 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: 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 Echosens devices

FDA 510(k) Submission Details - K150239

510(k) Number K150239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2015
Decision Date September 01, 2015
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
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 Consultant

Boston Medtech Advisors, Inc.
Zvi Ladin

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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 721
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K150239.
MD-2300S Ultrasonic A/B Scanner for Ophthalmology
K152318 · MEDA Co., Ltd. · Nov 2015
iLab Ultrasound Imaging System
K152316 · Boston Scientific · Sep 2015
SONON Ultrasound Imaging System (Model: SONON 300C)
K151339 · Healcerion Co., Ltd. · Sep 2015
Hi-Light Diagnostic Ultrasound Systems
K151709 · Qingdao Hisense Medical Equipment Co., Ltd. · Jul 2015
Ultrasound System SONIMAGE HS1
K151060 · Konica Minolta, Inc. · Jun 2015
FibroScan
K150949 · Echosens · Jun 2015