510(k) K991578

SMARTSPOT 2000 by Cmt Medical Technologies, Ltd. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1999
Date Received
May 6, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type