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 3D AND 3D+

K-Number: K091145 · 2009-05-27

ApplicantIsodose Control B.V.
Decision Date2009-05-27
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLEXIPLAN 3D AND 3D+ 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 2009-05-27 under 510(k) number K091145. 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 3D AND 3D+?

FLEXIPLAN 3D AND 3D+ is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Isodose Control B.V.. The 510(k) number is K091145.

When did FLEXIPLAN 3D AND 3D+ receive FDA 510(k) clearance?

FLEXIPLAN 3D AND 3D+ received FDA 510(k) clearance on 2009-05-27, under 510(k) number K091145.

Who is the listed applicant for FLEXIPLAN 3D AND 3D+?

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 3D AND 3D+?

The FDA product code for FLEXIPLAN 3D AND 3D+ 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.

K082530APPLICATORS FOR AFTERLOADING BRACHYTHERAPYK081112FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEMK070574FLEXITRON

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.

↑