VOLUMINA


Device Classification Name

system, image processing, radiological

510(k) Number K081215
Device Name VOLUMINA
Applicant
KJAYA MEDICAL, LLC
263 tresser blvd., 9th floor
stamford, 
CT 
06901

Applicant Contact kovalan muniandy
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 04/30/2008
Decision Date 08/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No