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FDA 510(k)

Respiratory Gating for Scanners v2.0

K-Number: K213927 · 2022-01-14

ApplicantVarian Medical Systems, Inc.
Decision Date2022-01-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Respiratory Gating for Scanners v2.0 is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-01-14 under approval number K213927. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Respiratory Gating for Scanners v2.0?

Respiratory Gating for Scanners v2.0 is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K213927.

When was Respiratory Gating for Scanners v2.0 approved by the FDA?

Respiratory Gating for Scanners v2.0 received FDA 510(k) clearance on 2022-01-14, under approval number K213927.

What company makes Respiratory Gating for Scanners v2.0?

Respiratory Gating for Scanners v2.0 is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Respiratory Gating for Scanners v2.0?

The FDA product code for Respiratory Gating for Scanners v2.0 is JAK.

Related Clinical Trials

NCT02434809 Respiratory Motion-Corrected Cone-Beam CT and Intratreatment Gating Based on Electromagnetic Transponders to Reduce Target Position Uncertainty in Radiation Treatment of Lung Malignancies ACTIVE_NOT_RECRUITING

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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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