OPEN BREAST COIL (OBC) WITH BIOPSY PLATES


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K050728
Device Name OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
Applicant
USA INSTRUMENTS, INC.
1515 danner dr.
aurora, 
OH 
44202

Applicant Contact david brown
Correspondent
USA INSTRUMENTS, INC.
1515 danner dr.
aurora, 
OH 
44202

Correspodent Contact david brown
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 03/21/2005
Decision Date 06/28/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No