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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 K001097
Device Name ACTIVE ARRAY CATHETER, MODEL CS-2000
Applicant
Image-Guided Neurologics, Inc.
2290 Eau Gallie Blvd.
Melbourne,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
Image-Guided Neurologics, Inc.
2290 Eau Gallie Blvd.
Melbourne,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/04/2000
Decision Date 01/18/2001
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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