Company: QTIWW
Filing Date: 2025-01-31
Form Type: S-1/A
Source: 0001628280-25-003316
Chunk: 232

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-01-31
Form: S-1/A
Chunk 232
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 88059928 |     |                   5991966 |     | 7/31/2018   |     | 9/24/2019     |     | 2/18/2020         |     | QT Imaging, Inc. |
| VOLOGRAPHY                          |     |  90329042 |     |                   7183396 |     | 11/19/2020  |     | 6/8/2021      |     | 10/3/2023         |     | QT Imaging, Inc. |
| QT IMAGING                          |     |  98800489 |     | In the publication period |     | 10/14/2024  |     |               |     |                   |     | QT Imaging, Inc. |
| Breast Acoustic CT                  |     |  98414186 |     | In the publication period |     | 2/21/2024   |     |               |     |                   |     | QT Imaging, Inc. |
| Breast ACT                          |     |  98414157 |     | In the publication period |     | 2/21/2024   |     |               |     |                   |     | QT Imaging, Inc. |
| Breast Acoustic Computed Tomography |     |  98414202 |     | In the publication period |     | 2/21/2024   |     |               |     |                   |     | QT Imaging, Inc. |

The Company is not aware of any research laboratories, commercial companies or universities developing ultra-low frequency transmitted sound imaging using inverse scattering image reconstruction. Therefore, the Company believes that its patent and proprietary position is currently substantial and a very valuable asset.

#### Government Regulation
Our existing product, the QT Breast Scanner, products under development, and our operations are subject to extensive regulation by the FDA, and other federal and state authorities in the U.S., as well as comparable authorities in foreign jurisdictions. Our products do not emit radiation, but are subject to regulation as medical devices in the U.S. under the FDCA and as implemented and enforced by the FDA, and under comparable regulatory schemes in foreign jurisdictions.

#### FDA Regulation of Medical Devices
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution,