Cleared Traditional

K113511 - ECHOSTAR SPICA 1.5T MR SYSTEM

K113511 is an FDA 510(k) clearance for ECHOSTAR SPICA 1.5T MR SYSTEM, manufactured by Alltech Medical Systems America, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K113511 · Alltech Medical Systems America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
156d
Days
Class 2
Risk

K113511 is an FDA 510(k) clearance for the ECHOSTAR SPICA 1.5T MR SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Alltech Medical Systems America, Inc. (Solon, US). The FDA issued a Cleared decision on May 2, 2012 after a review of 156 days - an extended review cycle.

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 Alltech Medical Systems America, Inc. devices

FDA 510(k) Submission Details - K113511

510(k) Number K113511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2011
Decision Date May 02, 2012
Days to Decision 156 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
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 872
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K113511.
S-SCAN
K121650 · Esaote, S.P.A. · Jul 2012
VANTAGE TITAN
K120638 · Toshibamedical Systems Corporation · Jun 2012
VANTAGE TITAN 3T
K120487 · Toshibamedical Systems Corporation · May 2012
ECHELON OVAL MRI SYSTEM
K113145 · Hitachi Medical Systems America, Inc. · May 2012
SPEEDUP SOFTWARE OPTION
K120748 · Esaote, S.P.A. · May 2012
VANTAGE TITAN 3T
K113093 · Toshibamedical Systems Corporation · Jan 2012