FDA device listing

Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA device listing 1143991582 · IRAY Imaging LLC

Key facts

Owner/operator IRAY Imaging LLC
Owner/operator number 10091237
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 LLC
Establishment registrations 3030898585
FEI numbers 3030898585
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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