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FDA 510(k)

QT Scanner 2000 Model A

K-Number: K190646 · 2019-10-18

ApplicantQt Ultrasound, LLC
Decision Date2019-10-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QT Scanner 2000 Model A is a medical device manufactured by Qt Ultrasound, LLC. It received FDA 510(k) clearance on 2019-10-18 under approval number K190646. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QT Scanner 2000 Model A?

QT Scanner 2000 Model A is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Qt Ultrasound, LLC. The 510(k) number is K190646.

When was QT Scanner 2000 Model A approved by the FDA?

QT Scanner 2000 Model A received FDA 510(k) clearance on 2019-10-18, under approval number K190646.

What company makes QT Scanner 2000 Model A?

QT Scanner 2000 Model A is manufactured by Qt Ultrasound, LLC.

What is the FDA product code for QT Scanner 2000 Model A?

The FDA product code for QT Scanner 2000 Model A is IYO.

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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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