FDA device listing

A1417MCW,A1717MCW,F1417MCW

FDA device listing 1452265094 · H&abyz

Key facts

Proprietary names A1417MCW,A1717MCW,F1417MCW
Owner/operator H&abyz
Owner/operator number 10062737
Premarket submissions K223930
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 H&ABYZ
Establishment registrations 3016674851
FEI numbers 3016674851
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