Company: QTIWW
Filing Date: 2025-12-29
Form Type: S-1/A
Source: 0001628280-25-058960
Chunk: 167

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-12-29
Form: S-1/A
Chunk 167
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 monitoring equipment and to demonstrate compliance with the “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment”. This test on acoustic output was pursuant to IEC 60601-2-37 Edition 2.0.2007 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Finally, system verification testing was conducted to ensure that the QT Breast Scanner met all design and other requirements including but not limited to that no new issues of safety or effectiveness compared to the predicate device, SoftVue System manufactured by Delphinus Medical Technologies, were raised.

On June 6, 2017, the FDA, in response to the Company’s Section 510(K) Summary of Safety and Effectiveness premarket notification, determined that the QT Breast Scanner is substantially equivalent to the predicate device. Our use of the words “safe”, “safety”, “effectiveness”, and “efficacy” in relation to the QT Breast Scanner in this prospectus and all other documents related to the Company is limited to the context of the Section 510(K) Summary of Safety and Effectiveness that was reviewed and responded to by the FDA.

The Company's Cloud SaaS platform will serve as the unified delivery framework for upcoming artificial intelligence/machine learning algorithms developed by the Company. Leveraging DICOM-compatible architecture, the Company will integrate these modules through the cloud for quantitative feature extraction and diagnostic decision support. Built on advanced acoustic signal analysis and volumetric data fusion, the algorithms will be deployed in real time through the cloud infrastructure. This approach will ensure that future artificial intelligence-driven advancements, such as automated lesion segmentation, volumetric tissue characterization, and computer-aided diagnosis, can be securely delivered to all connected QT Breast Scanners without requiring on-premise updates. As biomarkers allow us to move beyond detection toward diagnostic and prognostic precision through quantitative imaging, the goal is to build a biomarker-driven Cloud SaaS platform to shift from a hardware company to a precision imaging artificial intelligence platform combining hardware, software and cloud-based artificial intelligence modules.

#### The Cost and Accessibility of Healthcare
Medical imaging is an essential part of clinical diagnosis and is a requirement for making the best treatment decisions and improving a person’s health. Most people in the world live in low-resource environments and do not have access to advanced medical imaging—thus the absence of high-quality medical imaging in LREs is a significant obstacle to providing basic health care.

Even in advanced health care facilities in the U.S., where