Cleared Special

K131996 - S-SCAN

K131996 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 Special 510(k) pathway after a 168-day FDA review.

K131996 · Esaote, S.P.A. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
168d
Days
Class 2
Risk

K131996 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. (Indianpolis, US). The FDA issued a Cleared decision on December 13, 2013 after a review of 168 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K131996

510(k) Number K131996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2013
Decision Date December 13, 2013
Days to Decision 168 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
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Modification to existing cleared device.

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 Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 1109
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K131996 · S-SCAN
Download PDF FDA Summary Esaote, S.P.A.