QT Scanner 2000 Model A— 510(k) K253898
Substantially EquivalentQT Imaging Holdings, Inc.
FDA 510(k) clearance K253898 for QT Scanner 2000 Model A, Substantially Equivalent on 2026-03-04. Applicant: QT Imaging Holdings, Inc.. Device class: 2.
Clearance details
- Applicant
- QT Imaging Holdings, Inc.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Novato, CA, US
Recent devices under product code IYO
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.