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 the device name listed in this FDA 510(k) record. The listed applicant is Acoustic Medsystems, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) 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. The listed applicant is Acoustic Medsystems, Inc.. The 510(k) number is K150019.
When did TheraVision Ultrasound Ablation System and ACOUSTx Applicators receive FDA 510(k) clearance?
TheraVision Ultrasound Ablation System and ACOUSTx Applicators received FDA 510(k) clearance on 2016-01-13, under 510(k) number K150019.
Who is the listed applicant for TheraVision Ultrasound Ablation System and ACOUSTx Applicators?
The FDA 510(k) record lists Acoustic Medsystems, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
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.