K253898
- 510(k) number
- K253898
- Device name
- QT Scanner 2000 Model A
- Applicant
- QT Imaging Holdings, Inc. CA · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2026-03-04
- Date received
- 2025-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253898.pdf
Official FDA record: K253898
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.