Cleared Special

K052077 - G-SCAN CERVICAL SPINE COIL

K052077 is the FDA 510(k) clearance for G-SCAN CERVICAL SPINE COIL by Esaote, S.P.A.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 15-day FDA review.

K052077 · Esaote, S.P.A. · Radiology device
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Aug 2005
Decision
15d
Days
Class 2
Risk

K052077 is an FDA 510(k) clearance for the G-SCAN CERVICAL SPINE COIL. 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 August 16, 2005 after a review of 15 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 K052077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2005
Decision Date August 16, 2005
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 K052077.
1.5T 12 CHANNEL BODY ARRAY
K052584 · Usa Instruments, Inc. · Oct 2005
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3T HD BREAST ARRAY
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QD KNEE/FOOT COIL, MODEL MJQJ-147A
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OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728 · Usa Instruments, Inc. · Jun 2005
3.0T PROSTATE IMAGING SYSTEM
K051349 · Medrad, Inc. · Jun 2005