Cleared Traditional

SPINE COIL (K123708) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123708 · Usa Paramed Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
128d
Days
Class 2
Risk

K123708 is an FDA 510(k) clearance for the SPINE COIL. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Usa Paramed Medical Systems, Inc. (Morton Grove, US). The FDA issued a Cleared decision on April 10, 2013 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Usa Paramed Medical Systems, Inc. devices

Submission Details

510(k) Number K123708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date April 10, 2013
Days to Decision 128 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 107d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 77
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K123708.
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
K163661 · Rapid Biomedical GmbH · Mar 2018
Breast BI 7 MR Coil 1.5T Mammavention
K180123 · Noras Mri Products GmbH · Feb 2018
16ch T/R Hand Wrist Coil
K173469 · Quality Electrodynamics, LLC · Jan 2018
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275 · Siemens Medical Solutions USA, Inc. · Jan 2011
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA
K100141 · Siemens Medical Solutions USA, Inc. · Aug 2010
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · Siemens Medical Solutions USA, Inc. · Jan 2009