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510(k) Data Aggregation
K Number
K093336Device Name
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
Manufacturer
Date Cleared
2010-03-05
(130 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL NUMERICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Integrated Stimulus Delivery System (ISDS), both Optimum and Premium models, is indicated for use by trained medical professionals to aid in the performance of functional Magnetic Resonance Imaging (fMRI) examinations based on Blood Oxygen Level Dependent (BOLD) contrast. The ISDS works with GE 1.5T and 3.0T Magnetic Resonance (MR) scanners with BrainWave™ software installed. The ISDS presents to the patient specific visual and audio stimuli with predetermined order and timing patterns and collects keypad responses; all ISDS functions are synchronized with the ongoing patient MR imaging examination.
Device Description
For a patient undergoing a functional MR imaging examination the ISDS hardware components present visual and auditory stimuli to a patient and collect responses from that patient while the patient is in the bore of the MR scanner. Hardware components interface the ISDS computer system to the MR scanner in order to synchronize operation of the ISDS with the MR imaging procedure. The stimuli delivery (type of stimuli, stimuli presentation order, timing of stimuli presentation, etc.) is controlled by a proprietary software application.
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