FDA device listing

CT/ MR Tandem and Ovoid Set

FDA device listing 1966649089 · Varian Medical Systems, Inc

Key facts

Proprietary names CT/ MR Tandem and Ovoid Set
Owner/operator Varian Medical Systems, Inc
Owner/operator number 2914292
Premarket submissions K250299
Product codes JAQ
Device names JAQ - System, Applicator, Radionuclide, Remote-Controlled
Device class Class II
Classification regulations (21 CFR) 892.5700
Review panels Radiology
Registered establishments Varian Medical Systems Haan GmbH
Establishment registrations 3016602874
FEI numbers 3016602874
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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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