INSTARAD


Device Classification Name

system, image processing, radiological

510(k) Number K080334
Device Name INSTARAD
Applicant
MEDSPHERE TECHNOLOGIES PVT LTD.
1600 manchester way
corinth, 
TX 
76210

Applicant Contact carl alletto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 02/07/2008
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No