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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 K790975
Device Name SOMATOM 2
Applicant
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Siemens Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/23/1979
Decision Date 07/30/1979
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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