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510(k) Data Aggregation
K Number
K121239Device Name
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
Manufacturer
Date Cleared
2012-05-24
(30 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
OPTOACOUSTICS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs.
Device Description
Optoacoustic's MRI Multi-Channel Optical Communication System (MOC) is intended to facilitate audio communications and stimulation during a scanning session. System devices provide real-time Scanner noise reduction and/or noise cancellation, while enabling multiple concurrent dialogs. The MRI MOC comprises the following main component devices: IMROC, IMROC IR Wireless, and OptoACTIVE. Sub-component devices include Optical Headsets, Control/Mixing Console, Electro-Optical Unit (EOU), IR Transceiver Unit, Battery Recharging Unit, Hygienic Pop Screens, and Hygienic Earpad Covers.
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