510(k) K873075

ADAC MODEL ARC-5000, GAMMA CAMERA by Adac Laboratories — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1987
Date Received
August 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomographic, Nuclear
Device Class
Class II
Regulation Number
892.1310
Review Panel
RA
Submission Type