Cleared Traditional

K151668 - S-scan

K151668 is an FDA 510(k) clearance for S-scan, manufactured by Esaote, S.P.A.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K151668 · Esaote, S.P.A. · Radiology device
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Sep 2015
Decision
81d
Days
Class 2
Risk

K151668 is an FDA 510(k) clearance for the S-scan. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Esaote, S.P.A. (Genova, IT). The FDA issued a Cleared decision on September 8, 2015 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 - K151668

510(k) Number K151668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2015
Decision Date September 08, 2015
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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.
Kelli Anderson

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.

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All 967
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