DIGITAL IMAGING SYSTEM (BSR)


Device Classification Name

system, x-ray, angiographic

510(k) Number K991922
Device Name DIGITAL IMAGING SYSTEM (BSR)
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 north barrington rd.
hoffman estates, 
IL 
60195 -7372

Applicant Contact robert w callahan
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 north barrington rd.
hoffman estates, 
IL 
60195 -7372

Correspodent Contact robert w callahan
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 06/07/1999
Decision Date 09/01/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No