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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 K000359
Device Name EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO
Applicant
IMATRON, INC.
389 OYSTER POINT BLVD.
south san francisco,  CA  94080
Applicant Contact j.a. coduto
Correspondent
IMATRON, INC.
389 OYSTER POINT BLVD.
south san francisco,  CA  94080
Correspondent Contact j.a. coduto
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/04/2000
Decision Date 03/17/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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