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FDA 510(k)

3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION

K-Number: K131448 · 2013-07-26

ApplicantKoelis
Decision Date2013-07-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K131448. 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 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION?

3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Koelis. The 510(k) number is K131448.

When did 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION receive FDA 510(k) clearance?

3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION received FDA 510(k) clearance on 2013-07-26, under 510(k) number K131448.

Who is the listed applicant for 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION?

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 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION?

The FDA product code for 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION 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 SUITEK160357TRINITYK100793UROSTATION 3D PROSTATE SUITE

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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