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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 K103475
Device Name SPINEANALYER MODEL SAPOC
Applicant
Optasia Medical
Haw Bank House, High St.
Cheadle, Cheshire,  GB SK8 1AL
Applicant Contact ANTHONY HOLMES
Correspondent
Optasia Medical
Haw Bank House, High St.
Cheadle, Cheshire,  GB SK8 1AL
Correspondent Contact ANTHONY HOLMES
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/24/2010
Decision Date 01/05/2011
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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