FDA device listing

MOZART,XPERT 80,XPERT 80-L

FDA device listing 2016668629 · Kub Technologies

Key facts

Proprietary names MOZART,XPERT 80,XPERT 80-L
Owner/operator Kub Technologies
Owner/operator number 10028645
Premarket submissions K071233
Product codes MWP
Device names MWP - Cabinet, X-Ray System
Device class Class II
Classification regulations (21 CFR) 892.1680
Review panels Radiology
Registered establishments Kub Technologies, Inc.
Establishment registrations 3006051164
FEI numbers 3006051164
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings