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FDA 510(k)

QT Ultrasound Breast Scanner - 1

K-Number: K182213 · 2018-09-14

ApplicantQt Ultrasound, LLC
Decision Date2018-09-14
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QT Ultrasound Breast Scanner - 1 is a medical device manufactured by Qt Ultrasound, LLC. It received FDA 510(k) clearance on 2018-09-14 under approval number K182213. 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 Ultrasound Breast Scanner - 1?

QT Ultrasound Breast Scanner - 1 is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Qt Ultrasound, LLC. The 510(k) number is K182213.

When was QT Ultrasound Breast Scanner - 1 approved by the FDA?

QT Ultrasound Breast Scanner - 1 received FDA 510(k) clearance on 2018-09-14, under approval number K182213.

What company makes QT Ultrasound Breast Scanner - 1?

QT Ultrasound Breast Scanner - 1 is manufactured by Qt Ultrasound, LLC.

What is the FDA product code for QT Ultrasound Breast Scanner - 1?

The FDA product code for QT Ultrasound Breast Scanner - 1 is IYO.

Related Clinical Trials

NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT07216274 Quantitative Transmission Imaging Compared With MRI as Supplemental Screening for High Lifetime Risk of Breast Cancer COMPLETED NCT07600957 Polarized Light Therapy for Radiation Dermatitis in Breast Cancer RECRUITING NCT05972343 COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients RECRUITING NCT04047784 Pilot Study to Evaluate the Role of EBUS in the Diagnosis of Acute PE in Critically Ill Patients ENROLLING_BY_INVITATION NCT03607552 Non-contrast DWI for Supplemental Screening ACTIVE_NOT_RECRUITING

Other Devices by Qt Ultrasound, LLC

K162372QT Ultrasound Breast Scanner-1 K190646QT Scanner 2000 Model A

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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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