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FDA 510(k)

MODULEAF

K-Number: K030609 · 2003-03-17

ApplicantMrc Systems GmbH
Decision Date2003-03-17
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODULEAF 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 2003-03-17 under 510(k) number K030609. 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 MODULEAF?

MODULEAF is a medical device that received FDA 510(k) clearance on 2003-03-17. The listed applicant is Mrc Systems GmbH. The 510(k) number is K030609.

When did MODULEAF receive FDA 510(k) clearance?

MODULEAF received FDA 510(k) clearance on 2003-03-17, under 510(k) number K030609.

Who is the listed applicant for MODULEAF?

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 MODULEAF?

The FDA product code for MODULEAF 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.

K022307KONRAD, MODEL V.2.0K011816MINI MULTILEAF COLLIMATOR, MODEL KMI

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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