510(k) K210957

Kubec Xpert 80 Radiography System by Kub Technologies, Inc. — Product Code MWP

K210957 is an FDA 510(k) premarket notification submitted by Kub Technologies, Inc. for the device "Kubec Xpert 80 Radiography System". The FDA issued a decision of Substantially Equivalent on August 31, 2021. 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
August 31, 2021
Date Received
March 30, 2021
Clearance Type
Special
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