Cleared Special

K041145 - MODIFICATION TO E-SCAN XQ MRI SYSTEM

K041145 is the FDA 510(k) clearance for MODIFICATION TO E-SCAN XQ MRI SYSTEM by Esaote, S.P.A.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 11-day FDA review.

K041145 · Esaote, S.P.A. · Radiology device
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May 2004
Decision
11d
Days
Class 2
Risk

K041145 is an FDA 510(k) clearance for the MODIFICATION TO E-SCAN XQ MRI SYSTEM. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Esaote, S.P.A. (Indianpolis, US). The FDA issued a Cleared decision on May 14, 2004 after a review of 11 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 K041145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date May 14, 2004
Days to Decision 11 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
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
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 - MOS Coil, Magnetic Resonance, Specialty

All 300
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K041145.
GE SIGNA PROFILE 6 INCH GP COIL
K041921 · Ge Medical Systems, LLC · Jul 2004
MODEL BBC-127 BIOPSY BREAST COIL
K041481 · Mri Devices Corp. · Jul 2004
QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
K041487 · Usa Instruments, Inc. · Jun 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348 · Mri Devices Corp. · Mar 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · Mri Devices Corp. · Mar 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288 · Mri Devices Corp. · Mar 2004