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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scanner, Whole Body, Nuclear
510(k) Number K841996
Device Name MAXICAMERA 400T W/BODY CONTOUR TOMOGRA
Applicant
General Electric Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
General Electric Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1330
Classification Product Code
JAM  
Date Received05/16/1984
Decision Date 07/16/1984
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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