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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K112770
Device Name NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
Applicant
Ninepoint Medical, Inc.
1171 Barroihet Ave.,
Hillsborough,  CA  94010
Applicant Contact CINDY DOMECUS
Correspondent
Ninepoint Medical, Inc.
1171 Barroihet Ave.,
Hillsborough,  CA  94010
Correspondent Contact CINDY DOMECUS
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received09/23/2011
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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