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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K113748
Device Name IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
Applicant
Imris, Inc.
100-1370 Sony Pl.
Winnipeg, Mb,  CA R3T 1N5
Applicant Contact Sanjay Shah
Correspondent
Imris, Inc.
100-1370 Sony Pl.
Winnipeg, Mb,  CA R3T 1N5
Correspondent Contact Sanjay Shah
Regulation Number882.4460
Classification Product Code
HBL  
Date Received12/21/2011
Decision Date 03/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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