510(k) K944978

BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI by Bennett X-Ray Corp. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
October 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type