Spintech, Inc.

Address:30200 Telegraph Road,Bingham Farms,MI,48025,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (1) System, Nuclear Magnetic Resonance Imaging (LNH) (1)

Premarket Exempt

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STAGE - 00866463000410 Catalog Number : 200003

Device Description : STAGE works as a comprehensive brain imaging post-processing solution. The STAGE STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.

Device Class : 2

Duns Number: 105125594

Premarket Exempt : No

Product Code : LNH, LLZ

Prescription Use : Yes

Device Count : 1

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