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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 the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-02-12 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K203766.

When did 4D Integrated Treatment Console receive FDA 510(k) clearance?

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

Who is the listed applicant for 4D Integrated Treatment Console?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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