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Qt Ultrasound, LLC

FDA Regulatory Profile

Qt Ultrasound, LLC has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 30, 2026 · NAI
Latest 510(k)
Oct 18, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 30, 2026Novato, CADevicesNo Action Indicated (NAI)3011599810

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K190646QT Scanner 2000 Model AOct 18, 2019
K182213QT Ultrasound Breast Scanner - 1Sep 14, 2018
K162372QT Ultrasound Breast Scanner-1Jun 6, 2017

FDA data resources