K253902
- 510(k) number
- K253902
- Device name
- RealGUIDE
- Applicant
- 3DIEMME SRL IT
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-08-04
- Date received
- 2025-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253902.pdf
Official FDA record: K253902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.