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FDA 510(k)

MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)

K-Number: K090182 · 2009-05-04

ApplicantNuclemed S.A.
Decision Date2009-05-04
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) is the device name listed in this FDA 510(k) record. The listed applicant is Nuclemed S.A.. It received FDA 510(k) clearance on 2009-05-04 under 510(k) number K090182. 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 MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)?

MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) is a medical device that received FDA 510(k) clearance on 2009-05-04. The listed applicant is Nuclemed S.A.. The 510(k) number is K090182.

When did MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) receive FDA 510(k) clearance?

MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) received FDA 510(k) clearance on 2009-05-04, under 510(k) number K090182.

Who is the listed applicant for MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)?

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

What is the FDA product code for MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)?

The FDA product code for MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) 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.

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Other records listing Nuclemed S.A. 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.

K090190WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM

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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