IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K


Device Classification Name

system, x-ray, stationary

510(k) Number K072867
Device Name IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K
Applicant
IMIX ADR FINLAND OY
75 orchard spring ests
waterbury, 
VT 
05676

Applicant Contact james taylor
Correspondent
IMIX ADR FINLAND OY
75 orchard spring ests
waterbury, 
VT 
05676

Correspodent Contact james taylor
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 10/05/2007
Decision Date 11/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No