Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TrueBeam, TrueBeam STx, Edge, VitalBeam

K-Number: K213977 · 2022-06-03

ApplicantVarian Medical Systems, Inc.
Decision Date2022-06-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TrueBeam, TrueBeam STx, Edge, VitalBeam is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-06-03 under approval number K213977. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrueBeam, TrueBeam STx, Edge, VitalBeam?

TrueBeam, TrueBeam STx, Edge, VitalBeam is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K213977.

When was TrueBeam, TrueBeam STx, Edge, VitalBeam approved by the FDA?

TrueBeam, TrueBeam STx, Edge, VitalBeam received FDA 510(k) clearance on 2022-06-03, under approval number K213977.

What company makes TrueBeam, TrueBeam STx, Edge, VitalBeam?

TrueBeam, TrueBeam STx, Edge, VitalBeam is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for TrueBeam, TrueBeam STx, Edge, VitalBeam?

The FDA product code for TrueBeam, TrueBeam STx, Edge, VitalBeam is IYE.

Other Devices by Varian Medical Systems, Inc.

K162476Varian High Energy Linear Accelerator K160045Heyman Packing Applicator Set K161540Advanced Breast Template System K161576Esophagus Bougie Set K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths K160021Varian Sterilization Boxes

View all 83 devices →

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑