Cleared Special

K032121 - MODIFICATION TO E-SCAN XQ

K032121 is the FDA 510(k) clearance for MODIFICATION TO E-SCAN XQ by Esaote, S.P.A.. It is a Class 2 Radiology device (product code LNH) cleared through the Special 510(k) pathway after a 35-day FDA review.

K032121 · Esaote, S.P.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
35d
Days
Class 2
Risk

K032121 is an FDA 510(k) clearance for the MODIFICATION TO E-SCAN XQ. 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 August 13, 2003 after a review of 35 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 K032121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2003
Decision Date August 13, 2003
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
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 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 K032121.
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232 · Hitachi Medical Systems America, Inc. · Sep 2003
INTERA-SENSATION FAMILY
K031815 · Philips Medical Systems · Sep 2003
TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2
K032490 · Toshiba America Medical Systems, In.C · Aug 2003
GE DELTA SOFTWARE OPTION FOR MRI
K031927 · GE Medical Systems · Jul 2003
ECLIPSE
K030981 · Varian Medical Systems, Inc. · Jun 2003
ADVANTAGE WORKSTATION PASTING 1.1
K031396 · GE Medical Systems · May 2003