Company: QTIWW
Filing Date: 2025-11-03
Form Type: S-1
Source: 0001628280-25-048373
Chunk: 179

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-11-03
Form: S-1
Chunk 179
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 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 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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| Use of the QT Breast Scanner         |     | Value it Adds                                                                           |     | QT Timeframe* |
| Mass Size and Growth                 |     | Ability to measure response to treatment and assess mass stability                      |     | Short term    |
| A.I.-Based Mass Diagnostics          |     | Reduce unnecessary procedures (biopsies, additional imaging) by identifying lesion type |     | Short term    |
| Screening for High-Risk Young Women  |     | Provide young women a safe, comfortable, accurate method to screen for breast cancer    |     | Medium term   |
| Alternative to Screening Mammography |     | Provide all women a safe, comfortable, accurate method to screen for breast cancer      |     | Long term     |

Table 1

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* Note: the foregoing