K232613
- 510(k) number
- K232613
- Device name
- CT Cardiomegaly
- Applicant
- Innolitics, LLC TX · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-02-28
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K232613.pdf
Official FDA record: K232613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.