QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

About this update from Qt Imaging Holdings, Inc.

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality NOVATO, Calif., July 07, 2026 --( BUSINESS WIRE )-- QT Imaging Holdings, Inc. (Nasdaq: QTI) ("QT Imaging" or the "Company"), a medical device company engaged in the research, development, and commercialization of innovative body imaging systems, announces the successful completion of its first routine inspection by the U.S. Food and Drug Administration (FDA), with zero Form 483 observations. The FDA inspection reviewed QT Imaging's Quality Management System (QMS) and related processes that support the Company's operations, with no Form 483 observations issued. The inspector also provided positive feedback regarding the organization of QT Imaging's QMS and the Company's responsiveness throughout the inspection process. "The successful completion of our first FDA routine inspection with zero Form 483 observations is a significant operational achievement and a strong validation of the quality systems and processes we have established at QT Imaging," said Steve Choate, Chief Operating Officer of QT Imaging. "This outcome reflects the dedication of our team, the maturity of our Quality Management System, and our commitment to operational excellence. As we continue to scale manufacturing, expand commercialization globally, and support a growing customer base, maintaining the highest standards of quality and regulatory compliance will remain at the core of everything we do." An FDA Form 483 is issued at the conclusion of an inspection when an FDA investigator has observed conditions that may constitute violations of the Food, Drug and Cosmetic Act and related regulations. The absence of a Form 483 following QT Imaging's first FDA routine inspection represents an important operational milestone for the Company. About QT Imaging QT Imaging Holdings, Inc. (Nasdaq: QTI) is a medical device company engaged in the research, development, and commercialization of innovative imaging systems that use low-frequency sound waves. QT Imaging Holdings, Inc. strives to improve global health outcomes. Its strategy is predicated upon the fact that medical imaging is critical to the detection, diagnosis, and treatment of disease and that it should be safe, affordable, accessible, and centered on the patient's experience. For more information on QT Imaging Holdings, Inc., please visit the Company's website at www.qtimaging.com and follow us on LinkedIn .

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