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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K001870
Device Name MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL
Applicant
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Applicant Contact TORI BRUNS
Correspondent
Usa Instruments, Inc.
1515 Danner Dr.
Aurora,  OH  44202
Correspondent Contact TORI BRUNS
Regulation Number892.1000
Classification Product Code
MOS  
Date Received06/20/2000
Decision Date 08/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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