FDA 510(k)

OARtrac System with Patient Specific Reusable Universal PSD Sensors

Numéro K : K162954 · 2017-06-01

Date de décision2017-06-01

Code produitNZT

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

OARtrac System with Patient Specific Reusable Universal PSD Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Radiadyne, LLC. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K162954. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the OARtrac System with Patient Specific Reusable Universal PSD Sensors?

OARtrac System with Patient Specific Reusable Universal PSD Sensors is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Radiadyne, LLC. The 510(k) number is K162954.

When did OARtrac System with Patient Specific Reusable Universal PSD Sensors receive FDA 510(k) clearance?

OARtrac System with Patient Specific Reusable Universal PSD Sensors received FDA 510(k) clearance on 2017-06-01, under 510(k) number K162954.

Who is the listed applicant for OARtrac System with Patient Specific Reusable Universal PSD Sensors?

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

What is the FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors?

The FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors is NZT.

Essais cliniques associés

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Dispositifs connexes (Code : NZT)

K250083PRO-DOSE SystemNu-Rise, SA K182395OARtrac SystemRadialdyne, LLC

Source officielle

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