FDA device listing

ArcherQA

FDA device listing 1107524808 · Wisdom Technologies, Inc.

Key facts

Proprietary names ArcherQA
Owner/operator Wisdom Technologies, Inc.
Owner/operator number 10090500
Premarket submissions K231273
Product codes IYE
Device names IYE - Accelerator, Linear, Medical
Device class Class II
Classification regulations (21 CFR) 892.5050
Review panels Radiology
Registered establishments WISDOM TECHNOLOGIES, INC.
Establishment registrations 3031194398
FEI numbers 3031194398
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

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