Cleared Special

K183685 - O-Scan

K183685 is the FDA 510(k) clearance for O-Scan by Esaote, S.P.A.. It is a Class 2 Radiology device (product code LNH) cleared through the Special 510(k) pathway after a 25-day FDA review.

K183685 · Esaote, S.P.A. · Radiology device
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Jan 2019
Decision
25d
Days
Class 2
Risk

K183685 is an FDA 510(k) clearance for the O-Scan. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Esaote, S.P.A. (Genoa, IT). The FDA issued a Cleared decision on January 22, 2019 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Esaote, S.P.A. devices

Submission Details

510(k) Number K183685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2018
Decision Date January 22, 2019
Days to Decision 25 days
Submission Type Special
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
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.
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 - LNH System, Nuclear Magnetic Resonance Imaging

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