Cleared Traditional

K121239 - MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE (FDA 510(k) Clearance)

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

K121239 · Optoacoustics, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
30d
Days
Class 2
Risk

K121239 is an FDA 510(k) clearance for the MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS O.... Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Optoacoustics, Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on May 24, 2012 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Optoacoustics, Ltd. devices

Submission Details

510(k) Number K121239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2012
Decision Date May 24, 2012
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1097
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K121239.
APERTO Lucent MRI System
K253862 · Fujifilm Corporation · Apr 2026
S-scan Open (100001800)
K260746 · Esaote, S.P.A. · Mar 2026
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
K253625 · Canon Medical Systems Corporation · Mar 2026
nordicAudio (1.0)
K251937 · Nordicneurolab AS · Mar 2026
Embrace Neonatal MRI System
K254277 · Aspect Imaging, Ltd. · Mar 2026
LiverMultiScan (v6.0)
K253413 · Perspectum, Ltd. · Mar 2026