Cleared Special

A-CHANNELS LUMBAT SPINE COILS 17 (K110802) - FDA 510(k) Clearance

Also marketed or referenced as:
4-CHANNELS LUMBAR SPINE COILS 18

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K110802 · Esaote, S.P.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
16d
Days
Class 2
Risk

K110802 is an FDA 510(k) clearance for the A-CHANNELS LUMBAT SPINE COILS 17. 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 April 8, 2011 after a review of 16 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 K110802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2011
Decision Date April 08, 2011
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
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 431
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K110802.
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN
K123938 · Siemens Medical Solutions USA, Inc. · Feb 2013
MAGNETOM SPECTRA
K121160 · Siemens Medical Solutions USA, Inc. · Jul 2012
MAGNETOM AERA AND MAGNETOM SKYRA
K111242 · Siemens Medical Solutions USA, Inc. · Nov 2011
MAGNETOM AERA
K101347 · Siemens Medical Solutions USA, Inc. · Oct 2010
SYNGO BREVIS
K090038 · Siemens Medical Solutions USA, Inc. · Apr 2009
SYNGO MR B17
K082427 · Siemens Medical Solutions USA, Inc. · Nov 2008