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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K860472
Device Name NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
Applicant
Nuclear Diagnostics, Inc.
815 E. Locust
Springfield,  MO  65803
Applicant Contact MICHAEL DAVIS
Correspondent
Nuclear Diagnostics, Inc.
815 E. Locust
Springfield,  MO  65803
Correspondent Contact MICHAEL DAVIS
Regulation Number892.5780
Classification Product Code
IWE  
Date Received02/06/1986
Decision Date 07/03/1986
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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