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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 K954634
Device Name RADIOSURGERY VERIFICATION PHANTOM
Applicant
The Phantom Laboratory, Inc.
P.O. Box 511
Salem,  NY  12865
Applicant Contact JOSHUA R LEVY
Correspondent
The Phantom Laboratory, Inc.
P.O. Box 511
Salem,  NY  12865
Correspondent Contact JOSHUA R LEVY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/06/1995
Decision Date 12/22/1995
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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