FDA 510(k)

QT Scanner 2000 Model A

K-Number: K190646 · 2019-10-18

Decision Date2019-10-18

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QT Scanner 2000 Model A is the device name listed in this FDA 510(k) record. The listed applicant is Qt Ultrasound, LLC. It received FDA 510(k) clearance on 2019-10-18 under 510(k) 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. The listed applicant is Qt Ultrasound, LLC. The 510(k) number is K190646.

When did QT Scanner 2000 Model A receive FDA 510(k) clearance?

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

Who is the listed applicant for QT Scanner 2000 Model A?

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

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

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

Other records listing Qt Ultrasound, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182213QT Ultrasound Breast Scanner - 1 K162372QT Ultrasound Breast Scanner-1

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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.