510(k) K903160

LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS by Continental X-Ray Corp. — Product Code IXQ

K903160 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "LIEBEL-FLARSHEIM SERIES 8000 BUCKY,W/NON SIZE SENS". The FDA issued a decision of Substantially Equivalent on August 8, 1990. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1990
Date Received
July 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Stationary Top
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type