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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K780027
Device Name ACCELERATOR, LINEAR, MED.
Applicant
Emi Therapy Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Emi Therapy Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/04/1978
Decision Date 01/26/1978
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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