510(k) K950317

ADVANTX 1824 SPOTFILM DEVICE by GE Medical Systems — Product Code IXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1995
Date Received
January 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type