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FDA 510(k)

Respiratory Gating for Scanners (2.1)

K-Number: K253026 · 2026-06-04

ApplicantVarian Medical Systems, Inc.
Decision Date2026-06-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Respiratory Gating for Scanners (2.1) 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 2026-06-04 under 510(k) number K253026. 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 (2.1)?

Respiratory Gating for Scanners (2.1) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K253026.

When did Respiratory Gating for Scanners (2.1) receive FDA 510(k) clearance?

Respiratory Gating for Scanners (2.1) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253026.

Who is the listed applicant for Respiratory Gating for Scanners (2.1)?

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 Respiratory Gating for Scanners (2.1)?

The FDA product code for Respiratory Gating for Scanners (2.1) is JAK.

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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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