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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 K900170
Device Name MODIFIED EXEL 2400 ELITE/U & EXEL 2400E/U
Applicant
Elscint, Inc.
3550 Salt Creek Ln., Suite 105
Arlington Heights,  IL  60005
Applicant Contact ROCHELLE M SOBEL
Correspondent
Elscint, Inc.
3550 Salt Creek Ln., Suite 105
Arlington Heights,  IL  60005
Correspondent Contact ROCHELLE M SOBEL
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/12/1990
Decision Date 07/25/1990
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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