K253844
- 510(k) number
- K253844
- Device name
- AnyScan 3.0 NM Scanner Family
- Applicant
- Mediso Medical Imaging Systems, Ltd. HU
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-12-30
- Date received
- 2025-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K253844.pdf
Official FDA record: K253844
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.