FDA device listing

Vitalbeam v2.7

FDA device listing 1311332341 · Varian Medical Systems, Inc

Key facts

Proprietary names Vitalbeam v2.7
Owner/operator Varian Medical Systems, Inc
Owner/operator number 2914292
Premarket submissions K172013
Product codes IYE
Device names IYE - Accelerator, Linear, Medical
Device class Class II
Classification regulations (21 CFR) 892.5050
Review panels Radiology
Registered establishments Varian Medical Systems, Inc, Varian Medical Systems, Inc.
Establishment registrations 2916710, 3015548663
FEI numbers 2916710, 3015548663
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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