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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K812915
Device Name MX 125
Applicant
General Electric Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
General Electric Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1760
Classification Product Code
ITY  
Date Received10/19/1981
Decision Date 11/24/1981
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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