SPINEANALYER MODEL SAPOC


Device Classification Name

system, image processing, radiological

510(k) Number K103475
Device Name SPINEANALYER MODEL SAPOC
Applicant
OPTASIA MEDICAL
haw bank house, high street
cheadle, cheshire, 

GB

sk8 1al

Applicant Contact anthony holmes
Correspondent
OPTASIA MEDICAL
haw bank house, high street
cheadle, cheshire, 

GB

sk8 1al

Correspodent Contact anthony holmes
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 11/24/2010
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