510(k) K780395

IMAGER, BODY SECTION, RADIONUCLIDE by Union Carbide Corp. — Product Code IYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1978
Date Received
March 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scanner, Rectilinear, Nuclear
Device Class
Class I
Regulation Number
892.1300
Review Panel
RA
Submission Type