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FDA 510(k)

UROSTATION 3D PROSTATE SUITE

K-Number: K100793 · 2010-09-22

ApplicantKoelis
Decision Date2010-09-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UROSTATION 3D PROSTATE SUITE is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2010-09-22 under 510(k) number K100793. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROSTATION 3D PROSTATE SUITE?

UROSTATION 3D PROSTATE SUITE is a medical device that received FDA 510(k) clearance on 2010-09-22. The listed applicant is Koelis. The 510(k) number is K100793.

When did UROSTATION 3D PROSTATE SUITE receive FDA 510(k) clearance?

UROSTATION 3D PROSTATE SUITE received FDA 510(k) clearance on 2010-09-22, under 510(k) number K100793.

Who is the listed applicant for UROSTATION 3D PROSTATE SUITE?

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

What is the FDA product code for UROSTATION 3D PROSTATE SUITE?

The FDA product code for UROSTATION 3D PROSTATE SUITE is LLZ.

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Other records listing Koelis 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.

K180970Disposable guides KDNG00K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeK170521TRINITY/3D PROSTATE SUITEK160357TRINITYK1314483D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, 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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