510(k) K851685

DIGITAL GAMMA CAMERA GCA 601 E by Toshiba Medical Systems — Product Code JWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1985
Date Received
April 23, 1985
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