Cleared Traditional

K151466 - MrOpen

K151466 is an FDA 510(k) clearance for MrOpen, manufactured by Paramed S.R.L.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K151466 · Paramed S.R.L. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
136d
Days
Class 2
Risk

K151466 is an FDA 510(k) clearance for the MrOpen. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Paramed S.R.L. (Genoa, IT). The FDA issued a Cleared decision on October 15, 2015 after a review of 136 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 Paramed S.R.L. devices

FDA 510(k) Submission Details - K151466

510(k) Number K151466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date October 15, 2015
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
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 K151466.
MAGNETOM Amira
K152283 · Siemens Medical Solutions USA, Inc. · Dec 2015
SIGNA Pioneer
K153003 · Ge Healthcare · Oct 2015
Vantage Titan 3T
K152371 · Toshibamedical Systems Corporation · Oct 2015
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit
K151579 · Siemens Medical Solutions USA, Inc. · Sep 2015
S-scan
K151668 · Esaote, S.P.A. · Sep 2015
ECHELON Oval V 5.0 MRI System
K151015 · Hitachi Medical Systems America, Inc. · Jul 2015