SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION


Device Classification Name

system, x-ray, mobile

510(k) Number K080701
Device Name SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
Applicant
SHIMADZU CORP.
20101 south vermont ave.
torrance, 
CA 
90502 -1328

Applicant Contact don karle
Correspondent
SHIMADZU CORP.
20101 south vermont ave.
torrance, 
CA 
90502 -1328

Correspodent Contact don karle
Regulation Number 892.1720
Classification Product Code
IZL  
Date Received 03/11/2008
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls