Company: QTIWW
Filing Date: 2025-02-05
Form Type: 424B3
Source: 0001628280-25-004061
Chunk: 201

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-02-05
Form: 424B3
Chunk 201
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| The transducer array in the water bath 
 Image 2                                |     | Schematic of rotating ultrasound transmitter 
 Image 3                                      |

The QT Breast Scanner creates true 3D images of the patient’s breast viewable in the Quantitative Transmission Ultrasound Viewer (known as QTviewer®), a software product designed for healthcare professionals to view the transmission (speed of sound) and reflection images. This application can display correlated DICOM

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images in multiple orientations (coronal, sagittal, and axial). QTviewer can manipulate image views and analyze pixel data

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with various functions. The QTviewer has additional functionality which enables the user to measure mass size and volume as well as fibroglandular tissue volume. 16

Image 4 below is a still image of the viewer for a patient with a cyst. The transmission (top 3 panels) and reflection (bottom 3 panels) images as seen in coronal, axial, and sagittal representations.

<div align='center'>Image 4</div>

The QT Breast Scanner is the current version of the QT Breast Scanner and is FDA-cleared “for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.” 17

The QT Breast Scanner has current applicability as a supplementary imaging device (not as a replacement for screening mammography); near-term applicability for determining breast density, measuring mass size and growth,

16 See, American Association for Cancer Research, R. Natesan, J. Wiskin, S. Lee, B. H. Malik, Quantitative Assessment of Breast Density: Transmission Ultrasound is Comparable to Mammography with Tomosynthesis (Dec. 3, 2019), available at https://aacrjournals.org/cancerpreventionresearch/article/12/12/871/47203/Quantitative-Assessment-of-Breast-Density.

17 U.S Department of Health and Human Services, Food and Drug Administration, 510(k) number K162372.

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and diagnosing lesions using artificial intelligence; and medium- to long-term applicability for breast screening as shown in Table 1.

| Use of the QT Breast Scanner                                                                    |     | Value it Adds                                                                                                                                                                                                                                  |     | QT Timeframe* |
| Supplementary imaging                                                                           |     | Adjunct to screening mammography (