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FDA 510(k)

MINI MULTILEAF COLLIMATOR, MODEL KMI

K-Number: K011816 · 2001-09-07

ApplicantMrc Systems GmbH
Decision Date2001-09-07
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINI MULTILEAF COLLIMATOR, MODEL KMI is the device name listed in this FDA 510(k) record. The listed applicant is Mrc Systems GmbH. It received FDA 510(k) clearance on 2001-09-07 under 510(k) number K011816. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI MULTILEAF COLLIMATOR, MODEL KMI?

MINI MULTILEAF COLLIMATOR, MODEL KMI is a medical device that received FDA 510(k) clearance on 2001-09-07. The listed applicant is Mrc Systems GmbH. The 510(k) number is K011816.

When did MINI MULTILEAF COLLIMATOR, MODEL KMI receive FDA 510(k) clearance?

MINI MULTILEAF COLLIMATOR, MODEL KMI received FDA 510(k) clearance on 2001-09-07, under 510(k) number K011816.

Who is the listed applicant for MINI MULTILEAF COLLIMATOR, MODEL KMI?

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

What is the FDA product code for MINI MULTILEAF COLLIMATOR, MODEL KMI?

The FDA product code for MINI MULTILEAF COLLIMATOR, MODEL KMI is IXI.

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 Mrc Systems GmbH 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.

K030609MODULEAFK022307KONRAD, MODEL V.2.0

Related Devices (Code: IXI)

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.

K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLCK222639VHA Radiotherapy BolusVha DeanK214093VSP Bolus3D SystemsK132236.DECIMAL PROTON APERTURE.Decimal, Inc.K131150CURA COMPENSATORCura Medical Technologies, LLCK123893CURA COLLIMATORCura Medical Technologies, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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