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510(k) Data Aggregation
K Number
K060112Device Name
NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM
Manufacturer
NODECREST LLC
Date Cleared
2006-05-05
(108 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
NODECREST LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The range of Nodecrest Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system:
1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values
2) To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye.
The Nodecrest Transcranial Doppler is intended for use during:
- a) Diagnostic exams
b) Surgical interventions
The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
Device Description
The EMS9U range is a Transcranial Doppler (TCD) diagnostic ultrasound system, with a pulse wave and / or continuous wave Doppler transducer that can be used free hand (or head frame mounted for longer term monitoring). A supplementary M-mode disala ( nay be used to help locate blood flow signals to position the sample gate for Doppler signal, and for detection of emboli signals. Each of the three models in the range is identical in terms of hardware the difference being features that the end user does not request are turned off in the software.
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