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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K113832
Device Name SONICEYE ULTRASOUND TRANSDUCER
Applicant
Blacktoe Medical Iii, Inc.
8305 Creekside Pl.
Suite C
Beaverton,  OR  97008
Applicant Contact KENDRA RATHKEY
Correspondent
Blacktoe Medical Iii, Inc.
8305 Creekside Pl.
Suite C
Beaverton,  OR  97008
Correspondent Contact KENDRA RATHKEY
Regulation Number892.1570
Classification Product Code
ITX  
Date Received12/27/2011
Decision Date 03/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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