RESOLUTIONMD MOBILE MODEL RMB-MOB-2X


Device Classification Name

system, image processing, radiological

510(k) Number K111346
FOIA Releasable 510(k) K111346
Device Name RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
Applicant
CALGARY SCIENTIFIC, INC.
suite 208, 1210 20th avenue se
calgary, alberta, 

CA

t2g 1m8

Applicant Contact kyle peterson
Correspondent
CALGARY SCIENTIFIC, INC.
suite 208, 1210 20th avenue se
calgary, alberta, 

CA

t2g 1m8

Correspodent Contact kyle peterson
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/13/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No