510(k) K880982

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY by Orion Corporation Soredex — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1988
Date Received
March 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type