Company: QTIWW
Filing Date: 2025-12-31
Form Type: 424B3
Source: 0001628280-25-059235
Chunk: 180

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-12-31
Form: 424B3
Chunk 180
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 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

<div align='center'>110</div>

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, 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 (not a replacement), particularly for women with dense breasts to identify masses missed by mammography or provide additional information on masses seen, with the potential to reduce unnecessary procedures |     | Current       |
| Fibroglandular Tissue Volume & the Ratio of Fibroglandular Tissue Volume to Total Breast Volume |     | Ability to quantify this ratio (a risk factor for breast cancer), without compression or radiation of mammography                                                                                                                              |     | Current       |

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