510(k) K862416

FTI 100 MEDICAL THERMAL IMAGER by Parexel Intl. Corp. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1986
Date Received
June 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type