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FDA 510(k)

WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM

K-Number: K090190 · 2009-10-09

ApplicantNuclemed S.A.
Decision Date2009-10-09
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM 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 2009-10-09 under 510(k) number K090190. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM?

WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Nuclemed S.A.. The 510(k) number is K090190.

When did WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM receive FDA 510(k) clearance?

WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM received FDA 510(k) clearance on 2009-10-09, under 510(k) number K090190.

Who is the listed applicant for WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM?

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 WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM?

The FDA product code for WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM is HAW.

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.

K090182MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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