510(k) K855161

UPRIGHT BUCKY STAND/MOUNT by X-Ray Systems — Product Code KPR

K855161 is an FDA 510(k) premarket notification submitted by X-Ray Systems for the device "UPRIGHT BUCKY STAND/MOUNT". The FDA issued a decision of Substantially Equivalent on February 12, 1986. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. X-Ray Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1986
Date Received
December 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type