K230534
- 510(k) number
- K230534
- Device name
- BriefCase-Quantification
- Applicant
- Aidoc Medical , Ltd. IL
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2023-11-08
- Date received
- 2023-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K230534.pdf
Official FDA record: K230534
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.