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FDA 510(k)

TheraVision Ultrasound Ablation System and ACOUSTx Applicators

K-Number: K150019 · 2016-01-13

ApplicantAcoustic Medsystems, Inc.
Decision Date2016-01-13
Product CodeNTB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TheraVision Ultrasound Ablation System and ACOUSTx Applicators is a medical device manufactured by Acoustic Medsystems, Inc.. It received FDA 510(k) clearance on 2016-01-13 under approval number K150019. The device is classified under product code NTB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

TheraVision Ultrasound Ablation System and ACOUSTx Applicators is a medical device that received FDA 510(k) clearance on 2016-01-13. It is manufactured by Acoustic Medsystems, Inc.. The 510(k) number is K150019.

When was TheraVision Ultrasound Ablation System and ACOUSTx Applicators approved by the FDA?

TheraVision Ultrasound Ablation System and ACOUSTx Applicators received FDA 510(k) clearance on 2016-01-13, under approval number K150019.

What company makes TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

TheraVision Ultrasound Ablation System and ACOUSTx Applicators is manufactured by Acoustic Medsystems, Inc..

What is the FDA product code for TheraVision Ultrasound Ablation System and ACOUSTx Applicators?

The FDA product code for TheraVision Ultrasound Ablation System and ACOUSTx Applicators is NTB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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