MAUDE Adverse Event Report: QT IMAGING HOLDINGS, INC. QT SCANNER 2000 MODEL A; QTI BREAST ACOUSTIC CT SCANNER

Model Number	A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Mass (2439)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented for qtscan on (b)(6) 2025 for evaluation of a palpable lump in the right breast.She reported feeling a lump for 3 weeks and the technician form completed by the scan technologist at the clinic indicated that the lump was located at the 3 o'clock position, in the areolar edge of the right breast.However, subsequent handheld ultrasound (hhus) and diagnostic mammography performed at another facility on (b)(6) 2025, focused attention at the 10 o'clock position, which the report from the outside facility indicated was the site of the palpable lump denoted by the patient.The imaging report from the outside facility described a highly suspicious mass with recommendation for an ultrasound-guided core biopsy of the mass in the right breast at 10 o'clock.
Additional Manufacturer Narrative
The medwatch report mw5176662 alleges "false advertising" and a failure to detect an abnormality that may be malignant.Qti's labeling and related materials aligned with the qt scanner 2000 model a's 510(k) clearance (k220933).There is no evidence of a device failure or malfunction.

• Brand Name: QT SCANNER 2000 MODEL A
• Common Device Name: QTI BREAST ACOUSTIC CT SCANNER
• Manufacturer (Section D): QT IMAGING HOLDINGS, INC.; 3 hamilton landing; suite 160; novato CA 94949
• Manufacturer (Section G): QT IMAGING HOLDINGS, INC.; three hamilton landing; suite 160; novato CA 94949
• Manufacturer Contact: sylvia arias-montez ; three hamilton landing; suite 160; novato, CA 94949 ; 4158427413
• MDR Report Key: 23433033
• Report Number: 3011599810-2025-00001
• Device Sequence Number: 4758422
• Product Code: IYO
• UDI-Device Identifier: 00852619008003
• UDI-Public: (01)00852619008003(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K220933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A
• Device Catalogue Number: 100366
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female