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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K001550
Device Name EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR
Applicant
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Applicant Contact J. A CODUTO
Correspondent
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Correspondent Contact J. A CODUTO
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received05/18/2000
Decision Date 12/11/2000
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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