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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K052587
Device Name 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
Applicant
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Applicant Contact KEITH A BARRITT
Correspondent
J. Morita USA, Inc.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Correspondent Contact KEITH A BARRITT
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/20/2005
Decision Date 12/27/2005
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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