510(k) K920393

MU125M MOBILE X-RAY SYSTEM by Shimadzu Medical Systems — Product Code IZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1992
Date Received
January 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Photofluorographic
Device Class
Class II
Regulation Number
892.1730
Review Panel
RA
Submission Type