510(k) K841996

MAXICAMERA 400T W/BODY CONTOUR TOMOGRA by General Electric Co. — Product Code JAM

K841996 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "MAXICAMERA 400T W/BODY CONTOUR TOMOGRA". The FDA issued a decision of Substantially Equivalent on July 16, 1984. The device falls under product code JAM (Scanner, Whole Body, Nuclear), a Class I device regulated under 21 CFR 892.1330. General Electric Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1984
Date Received
May 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scanner, Whole Body, Nuclear
Device Class
Class I
Regulation Number
892.1330
Review Panel
RA
Submission Type