K243688
- 510(k) number
- K243688
- Device name
- Saige-Dx (3.1.0)
- Applicant
- DeepHealth, Inc. MA · US
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2024-12-19
- Date received
- 2024-11-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243688.pdf
Official FDA record: K243688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.