FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K051025
Device Name FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Applicant Contact daniel f phelan
Correspondent
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Correspodent Contact daniel f phelan
Regulation Number 892.1650
Classification Product Code
JAA  
Date Received 04/22/2005
Decision Date 05/13/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls