FDA 510(k)

QT Scanner 2000 Model A

K-Number: K220933 · 2022-08-31

Decision Date2022-08-31

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QT Scanner 2000 Model A is a medical device manufactured by Qt Imaging, Inc.. It received FDA 510(k) clearance on 2022-08-31 under approval number K220933. 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 2022-08-31. It is manufactured by Qt Imaging, Inc.. The 510(k) number is K220933.

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

QT Scanner 2000 Model A received FDA 510(k) clearance on 2022-08-31, under approval number K220933.

What company makes QT Scanner 2000 Model A?

QT Scanner 2000 Model A is manufactured by Qt Imaging, Inc..

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

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