510(k) K854459

TBX MEDICAL X-RAY TABLE by Gendex Corp. — Product Code IXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1986
Date Received
November 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Radiographic
Device Class
Class I
Regulation Number
892.1910
Review Panel
RA
Submission Type