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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K082228
Device Name PLANISIGHT LINASYS
Applicant
Pathfinder Therapeutics, Inc.
2969 Armory Dr.
Suite 100a
Nashville,  TN  37204
Applicant Contact JAMES D STEFANSIC
Correspondent
Pathfinder Therapeutics, Inc.
2969 Armory Dr.
Suite 100a
Nashville,  TN  37204
Correspondent Contact JAMES D STEFANSIC
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/07/2008
Decision Date 09/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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