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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 the device name listed in this FDA 510(k) record. The listed applicant is Qt Ultrasound, LLC. It received FDA 510(k) clearance on 2018-09-14 under 510(k) 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. The listed applicant is Qt Ultrasound, LLC. The 510(k) number is K182213.

When did QT Ultrasound Breast Scanner - 1 receive FDA 510(k) clearance?

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

Who is the listed applicant for QT Ultrasound Breast Scanner - 1?

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 Ultrasound Breast Scanner - 1?

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

Related Clinical Trials

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.

NCT06878547VisR Ultrasound for Noninvasively Interrogating Stromal Collagen Organization in Women as a Breast Cancer Biomarker: Evaluation of Anisotropy in Cancer PatientsRECRUITINGNCT07273565Feasibility of Comparing Microwave Images to Clinical Information in Patients Recalled for Follow-up Breast ImagingENROLLING_BY_INVITATION

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.

K190646QT Scanner 2000 Model AK162372QT Ultrasound Breast Scanner-1

Related Devices (Code: IYO)

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.

K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.K253714IntraSight PlusPhilips Image Guided Therapy Corporation

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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