510(k) K952456

IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM by Fisher Imaging Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1995
Date Received
May 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type