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FDA 510(k)

4D Integrated Treatment Console

K-Number: K203766 · 2021-02-12

ApplicantVarian Medical Systems, Inc.
Decision Date2021-02-12
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

4D Integrated Treatment Console is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-02-12 under approval number K203766. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4D Integrated Treatment Console?

4D Integrated Treatment Console is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K203766.

When was 4D Integrated Treatment Console approved by the FDA?

4D Integrated Treatment Console received FDA 510(k) clearance on 2021-02-12, under approval number K203766.

What company makes 4D Integrated Treatment Console?

4D Integrated Treatment Console is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for 4D Integrated Treatment Console?

The FDA product code for 4D Integrated Treatment Console is MUJ.

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Related PubMed Literature

PMID: 40206536 A Blueprint for Clinical-Driven Medical Device Development: The Feverkidstool Application to Identify Children With Serious Bacterial Infection. Mayo Clinic proceedings. Digital health (2024)

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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.

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