510(k) K071233

XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM by Kub Technologies, Inc. — Product Code MWP

K071233 is an FDA 510(k) premarket notification submitted by Kub Technologies, Inc. for the device "XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 2007. The device falls under product code MWP (Cabinet, X-Ray System), a Class II device regulated under 21 CFR 892.1680. Kub Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2007
Date Received
May 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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