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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 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 2022-01-14 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K213927.

When did Respiratory Gating for Scanners v2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Respiratory Gating for Scanners v2.0?

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 v2.0?

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

Other records listing Varian Medical Systems, Inc. as applicant

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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Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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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