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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K062141
Device Name MAMMOPAD RADIOLUCENT CUSHION
Applicant
Biolucent, Inc.
6 Journey, Suite 325
Aliso Viejo,  CA  92656
Applicant Contact SHERYL HIGGINS
Correspondent
Biolucent, Inc.
6 Journey, Suite 325
Aliso Viejo,  CA  92656
Correspondent Contact SHERYL HIGGINS
Regulation Number892.1100
Classification Product Code
IYX  
Subsequent Product Code
IZH  
Date Received07/27/2006
Decision Date 09/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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