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FDA 510(k)

Precision Treatment Planning System

K-Number: K161136 · 2016-06-24

ApplicantAccuray Incorporated
Decision Date2016-06-24
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Precision Treatment Planning System is the device name listed in this FDA 510(k) record. The listed applicant is Accuray Incorporated. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K161136. 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 Precision Treatment Planning System?

Precision Treatment Planning System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Accuray Incorporated. The 510(k) number is K161136.

When did Precision Treatment Planning System receive FDA 510(k) clearance?

Precision Treatment Planning System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K161136.

Who is the listed applicant for Precision Treatment Planning System?

The FDA 510(k) record lists Accuray Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Treatment Planning System?

The FDA product code for Precision Treatment Planning System is MUJ.

Other records listing Accuray Incorporated 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: 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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