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FDA 510(k)

VITESSE 3.0

K-Number: K123152 · 2012-12-07

ApplicantVarian Medical Systems, Oncology Systems
Decision Date2012-12-07
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITESSE 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Oncology Systems. It received FDA 510(k) clearance on 2012-12-07 under 510(k) number K123152. 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 VITESSE 3.0?

VITESSE 3.0 is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is Varian Medical Systems, Oncology Systems. The 510(k) number is K123152.

When did VITESSE 3.0 receive FDA 510(k) clearance?

VITESSE 3.0 received FDA 510(k) clearance on 2012-12-07, under 510(k) number K123152.

Who is the listed applicant for VITESSE 3.0?

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

What is the FDA product code for VITESSE 3.0?

The FDA product code for VITESSE 3.0 is MUJ.

Related Clinical Trials

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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Other records listing Varian Medical Systems, Oncology Systems 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.

K103394BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)K101294PT2 VARIAN PROTON THERAPY SYSTEMK101751VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR

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.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

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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