TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001


Device Classification Name

cabinet,x-ray system

510(k) Number K111508
Device Name TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Applicant Contact deborah thomas
Correspondent
HOLOGIC, INC.
35 crosby dr.
bedford, 
MA 
01730

Correspodent Contact deborah thomas
Regulation Number 892.1680
Classification Product Code
MWP  
Date Received 06/01/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No