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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 K141787
Device Name SAGITTILT
Applicant
Orfit Industries NV
10882 Stonington Ave.
Fort Myers,  FL  33913
Applicant Contact Lee Leichter
Correspondent
Orfit Industries NV
10882 Stonington Ave.
Fort Myers,  FL  33913
Correspondent Contact Lee Leichter
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/02/2014
Decision Date 08/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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