DELTAVIEW MODEL 2.1


Device Classification Name

system, image processing, radiological

510(k) Number K111776
Device Name DELTAVIEW MODEL 2.1
Applicant
RIVERAIN MEDICAL GROUP,LLC
3020 south tech blvd.
miamisburg, 
OH 
45342 -4860

Applicant Contact jennifer v butsch
Correspondent
RIVERAIN MEDICAL GROUP,LLC
3020 south tech blvd.
miamisburg, 
OH 
45342 -4860

Correspodent Contact jennifer v butsch
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/23/2011
Decision Date 12/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Clinical Trials NCT01261507
Reviewed by Third Party No

Combination Product

No