K254001
- 510(k) number
- K254001
- Device name
- VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
- Applicant
- Spectrum Dynamics Medical, Ltd. IL
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2026-01-13
- Date received
- 2025-12-15
- 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: K254001.pdf
Official FDA record: K254001
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.