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FDA 510(k)

ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING

K-Number: K113102 · 2011-12-12

ApplicantNucletron
Decision Date2011-12-12
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING is the device name listed in this FDA 510(k) record. The listed applicant is Nucletron. It received FDA 510(k) clearance on 2011-12-12 under 510(k) number K113102. 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 ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING?

ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING is a medical device that received FDA 510(k) clearance on 2011-12-12. The listed applicant is Nucletron. The 510(k) number is K113102.

When did ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING receive FDA 510(k) clearance?

ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING received FDA 510(k) clearance on 2011-12-12, under 510(k) number K113102.

Who is the listed applicant for ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING?

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

What is the FDA product code for ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING?

The FDA product code for ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING is MUJ.

Related Clinical Trials

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Other records listing Nucletron 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.

K112420ONCENTRA PROSTATE 4.0K111973VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET

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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