510(k) K781676

X-RAY STAND, PORTABLE by General X-Ray, Inc. — Product Code IZL

K781676 is an FDA 510(k) premarket notification submitted by General X-Ray, Inc. for the device "X-RAY STAND, PORTABLE". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. General X-Ray, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1978
Date Received
September 29, 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