Cleared Traditional

K173034 - FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

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
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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
Combination Product No
PCCP Authorized No
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 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
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