Cleared Traditional

K061429 - DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN

K061429 is the FDA 510(k) clearance for DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN by Esaote, S.P.A.. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K061429 · Esaote, S.P.A. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2006
Decision
63d
Days
Class 2
Risk

K061429 is an FDA 510(k) clearance for the DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Esaote, S.P.A. (Carmel, US). The FDA issued a Cleared decision on July 25, 2006 after a review of 63 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

Submission Details

510(k) Number K061429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2006
Decision Date July 25, 2006
Days to Decision 63 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
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 817
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K061429.
EXCELART VANTAGE ATLAS, MODEL MRT-1503
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MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
K062454 · Siemens Medi Cal Solutions, Inc. · Nov 2006
G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004
K060956 · Esaote, S.P.A. · May 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
K053309 · Hitachi Medical Systems America, Inc. · Jan 2006
EXCELART VANTAGE ZGV
K060003 · Toshibamedical Systems Corporation · Jan 2006