Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM

K-Number: K081112 · 2008-07-29

ApplicantIsodose Control B.V.
Decision Date2008-07-29
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isodose Control B.V.. It received FDA 510(k) clearance on 2008-07-29 under 510(k) number K081112. 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 FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM?

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-29. The listed applicant is Isodose Control B.V.. The 510(k) number is K081112.

When did FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM receive FDA 510(k) clearance?

FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM received FDA 510(k) clearance on 2008-07-29, under 510(k) number K081112.

Who is the listed applicant for FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM?

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

What is the FDA product code for FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM?

The FDA product code for FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Isodose Control B.V. 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.

K091145FLEXIPLAN 3D AND 3D+K082530APPLICATORS FOR AFTERLOADING BRACHYTHERAPYK070574FLEXITRON

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.

↑