FDA 510(k)

TRINITY/3D PROSTATE SUITE

K-Number: K170521 · 2017-05-30

ApplicantKoelis

Decision Date2017-05-30

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TRINITY/3D PROSTATE SUITE is a medical device manufactured by Koelis. It received FDA 510(k) clearance on 2017-05-30 under approval number K170521. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRINITY/3D PROSTATE SUITE?

TRINITY/3D PROSTATE SUITE is a medical device that received FDA 510(k) clearance on 2017-05-30. It is manufactured by Koelis. The 510(k) number is K170521.

When was TRINITY/3D PROSTATE SUITE approved by the FDA?

TRINITY/3D PROSTATE SUITE received FDA 510(k) clearance on 2017-05-30, under approval number K170521.

What company makes TRINITY/3D PROSTATE SUITE?

TRINITY/3D PROSTATE SUITE is manufactured by Koelis.

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

The FDA product code for TRINITY/3D PROSTATE SUITE is IYN.

Other Devices by Koelis

K160357TRINITY K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range K180970Disposable guides KDNG00

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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.