INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K111098
Device Name INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
Applicant
IMAGING DYNAMICS COMPANY LTD.
8870 ravello ct
naples, 
FL 
34114

Applicant Contact daniel kamm
Correspondent
IMAGING DYNAMICS COMPANY LTD.
8870 ravello ct
naples, 
FL 
34114

Correspodent Contact daniel kamm
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 04/20/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No