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U.S. Department of Health and Human Services

Product Classification
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Device headframe
Definition To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke.
Physical State made of mostly plastic and has an adjustable frame
Technical Method Uses ultrasound transducers mounted on a headframe to deliver transcranial ultrasound at diagnostic levels.
Target Area Head
Review Panel Neurology
Product CodeOVC
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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