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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K860193
Device Name PORTALCAST
Applicant
Diacor, Inc.
3191 S. 3300 E.,
Suite 100-A
Salt Lake City,  UT  84109
Applicant Contact GLENN N WATERMAN
Correspondent
Diacor, Inc.
3191 S. 3300 E.,
Suite 100-A
Salt Lake City,  UT  84109
Correspondent Contact GLENN N WATERMAN
Regulation Number892.5710
Classification Product Code
IXI  
Date Received01/22/1986
Decision Date 01/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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