Cleared Traditional

K162290 - MyLabSix CrystaLine

K162290 is an FDA 510(k) clearance for MyLabSix CrystaLine, manufactured by Esaote, S.P.A.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K162290 · Esaote, S.P.A. · Radiology device
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Oct 2016
Decision
60d
Days
Class 2
Risk

K162290 is an FDA 510(k) clearance for the MyLabSix CrystaLine. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Esaote, S.P.A. (Genova, IT). The FDA issued a Cleared decision on October 14, 2016 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - 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 Esaote, S.P.A. devices

FDA 510(k) Submission Details - K162290

510(k) Number K162290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2016
Decision Date October 14, 2016
Days to Decision 60 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
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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

Navigant Consulting, Inc.
ALLISON SCOTT

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 - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1098
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