FDA device listing

SYNGO RT INTERFACE

FDA device listing 1050617157 · Varian Medical Systems, Inc

Key facts

Proprietary names SYNGO RT INTERFACE
Owner/operator Varian Medical Systems, Inc
Owner/operator number 2914292
Premarket submissions K120363
Product codes LLZ, MUJ
Device names LLZ - System, Image Processing, Radiological, MUJ - System, Planning, Radiation Therapy Treatment
Device class Class II
Classification regulations (21 CFR) 892.2050, 892.5050
Review panels Radiology
Registered establishments Siemens Healthineers AG Varian Cancer Therapy (CTH)
Establishment registrations 3006894636
FEI numbers 3006894636
Establishment operations Complaint File Establishment
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None 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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