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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 K942346
Device Name IMAGERT
Applicant
Impac Medical Systems, Inc.
209 Hamilton Ave.
Palo Alto,  CA  94301
Applicant Contact JOSEPH K JACHNOWSKI
Correspondent
Impac Medical Systems, Inc.
209 Hamilton Ave.
Palo Alto,  CA  94301
Correspondent Contact JOSEPH K JACHNOWSKI
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LMD  
Date Received05/16/1994
Decision Date 05/15/1995
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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