510(k) K781030

X-RAY UNIT, PORTABLE GX-101 AEC by General X-Ray, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1978
Date Received
June 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type