FDA device listing

Venu1717X

FDA device listing 1527234872 · iRay Imaging Technology Taicang Limited

Key facts

Proprietary names Venu1717X
Owner/operator iRay Imaging Technology Taicang Limited
Owner/operator number 10058988
Product codes MQB
Device names MQB - Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device class Class II
Classification regulations (21 CFR) 892.1680
Review panels Radiology
Registered establishments iRay Imaging Technology Taicang Limited
Establishment registrations 3014544225
FEI numbers 3014544225
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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

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