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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K980959
Device Name VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
PO BOX 170
TIRAT HACARMEL,  IL 30200
Applicant Contact YAIR FRIEDMAN
Correspondent
GE MEDICAL SYSTEMS F.I. HAIFA
PO BOX 170
TIRAT HACARMEL,  IL 30200
Correspondent Contact YAIR FRIEDMAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/14/1998
Decision Date 06/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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