K240417
- 510(k) number
- K240417
- Device name
- ProFound Detection (V4.0)
- Applicant
- Icad, Inc. NH · US
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2024-11-08
- Date received
- 2024-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240417.pdf
Official FDA record: K240417
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.